Cardiovascular FDA 510(k) clearances, last 90 days
US companies with an FDA 510(k) clearance in Cardiovascular from Aug 2, 2026 to Oct 30, 2026. FDA data through October 30, 2026.
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Last 90 days
74 clearances in the last 90 days. The same 90 days a year earlier: 49.
For contract manufacturers and test labs
Cardiovascular accounts for 74 US 510(k) clearances in the last 90 days. The product code with the most clearances in this window is QJP (Catheter, Percutaneous, Neurovasculature). Contract manufacturers and test labs that work on Cardiovascular devices can read the company, the device and the date below, then open the FDA record. Contacts for these companies come with a free month.
Top product codes
| Product code | Device type | Clearances |
|---|---|---|
QJP | Catheter, Percutaneous, Neurovasculature | 7 |
DQK | Computer, Diagnostic, Programmable | 5 |
NRY | Catheter, Thrombus Retriever | 5 |
QEW | Peripheral Mechanical Thrombectomy With Aspiration | 5 |
MOF | Guide, Wire, Catheter, Neurovasculature | 4 |
| Decision date | Company | Device | FDA record |
|---|---|---|---|
| Oct 30, 2026 | Medivance, Inc. | Arctic Sun Neonatal ArcticGel Pad | K263587 |
| Oct 30, 2026 | AngioDynamics, Inc. | AngioVac F1885 | K263076 |
| Oct 30, 2026 | Cb Innovations, LLC | EXG PulseLinQ Cables (EXGPL) | K262816 |
| Oct 30, 2026 | Catheter Precision, Inc. | VIVO (9002) | K261886 |
| Oct 29, 2026 | Medtronic, Inc. | DLP Coronary Ostial Cannulae | K263596 |
| Oct 29, 2026 | Cleerly, Inc. | Cleerly ISCHEMIA | K262839 |
| Oct 28, 2026 | Lymphatech, Inc. | LymphaTech Mobile 3D Measuring Tool | K261628 |
| Oct 27, 2026 | Transonic Systems, Inc. | FlowXL System: FlowXL Flowmeter and compatible Flowprobes and Flowsensors | K261714 |
| Oct 27, 2026 | Tactile Medical | Nimbl Pneumatic Compression System | K260586 |
| Oct 26, 2026 | Expanse Medical, Inc. | FLOWRUNNER Aspiration System | K262864 |
| Oct 23, 2026 | Monebo Technologies, Inc. | Kinetic Software Library | K260640 |
| Oct 21, 2026 | Toro Neurovascular, Inc. | Toro 71 Aspiration Catheter; Toro Aspiration Tubing | K262021 |
| Oct 21, 2026 | Aventusoft, LLC | Hemotag Analysis Software (HAS) | K252736 |
| Oct 19, 2026 | Innovative Health, LLC | Reprocessed BRK Transseptal Needle | K262917 |
| Oct 16, 2026 | Route 92 Medical, Inc. | Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set | K263266 |
| Oct 16, 2026 | Analog Devices | Sensinel Cardiopulmonary Management (CPM) System | K260801 |
| Oct 15, 2026 | Penumbra, Inc. | INDIGO Aspiration System | K262904 |
| Oct 15, 2026 | Circadia Health, Inc. | The Circadia CX00 System (CX00) | K262447 |
| Oct 14, 2026 | Masimo Corporation | Radius VSM and Accessories | K260676 |
| Oct 9, 2026 | Stryker Neurovascular | Excelsior Reach Microcatheter | K261649 |
| Oct 7, 2026 | Ceiba Healthcare US, Inc. | eClinics | K260075 |
| Oct 6, 2026 | Okami Medical, Inc. | LOBO Vascular Occlusion System | K262798 |
| Oct 6, 2026 | Bayer Medical Care, Inc. | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD IS12 Module (IS12); MEDRAD Imaging Bulk Package Transfer Spike | K262043 |
| Oct 6, 2026 | Alembic, LLC | APRO 88 Catheter | K261938 |
| Oct 5, 2026 | HeartSciences, Inc. | MyoVista wavECG (DG-200-B15-003) | K260005 |
| Oct 2, 2026 | Cognition Medical Corp. | OAB Delivery Catheter | K253422 |
| Oct 1, 2026 | Centerline Biomedical | Intra-Operative Positioning System (IOPS) and IOPS Visionary System | K263016 |
| Sep 29, 2026 | Elucid Bioimaging, Inc. | Elucid FFR-IQ (B.1) | K262015 |
| Sep 29, 2026 | QT Medical, Inc. | QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) | K260250 |
| Sep 25, 2026 | Tempus AI, Inc. | Tempus ECG-MR | K254297 |
| Sep 25, 2026 | Life Detection Technologies | DistaSense(TM) (v1) | K254058 |
| Sep 21, 2026 | Trisalus Life Sciences | TriSalus TriNav Advance Infusion System | K253509 |
| Sep 18, 2026 | Vantis Vascular, Inc. | CrossFAST Integrated Microcatheter Advanced Delivery System | K262817 |
| Sep 18, 2026 | Epic Systems Corporation | Deterioration Index Version 2 | K260008 |
| Sep 18, 2026 | Inari Medical, Inc. | Triever Duo Catheter | K253419 |
| Sep 17, 2026 | Abbott Medical | EnSite X EP System | K261729 |
| Sep 16, 2026 | Route 92 Medical, Inc. | Route 92 Medical Full Length 046 Access System | K260220 |
| Sep 16, 2026 | Scientia Vascular | Aristotle 65 Macrowire | K254181 |
| Sep 14, 2026 | Maduro Medical, Inc. | Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit | K261089 |
| Sep 11, 2026 | Bio Compression Systems, Inc. | Sequential Circulator (SC-4004-DL, SC-4008-DL) | K261807 |
| Sep 11, 2026 | Zbeats, Inc. | ZBPro Diagnostic (Version 2.0) | K261580 |
| Sep 10, 2026 | OMRON Healthcare, Inc. | Upper Arm Blood pressure monitor (BP7155D) | K261929 |
| Sep 10, 2026 | Siemens Medical Solutions USA, Inc. | ACUNAV Luxera 4D ICE Catheter | K261696 |
| Sep 10, 2026 | Procerus Enterprises | TruPress | K254074 |
| Sep 8, 2026 | Emboline, Inc. | Emboliner Embolic Protection System (EPC-03) | K261715 |
| Sep 4, 2026 | Piraeus Medical, Inc. | 70 NeuGlide Catheter | K262277 |
| Sep 4, 2026 | Peerbridge Health, Inc. | Peerbridge COR MDx (Cor MDx) | K253529 |
| Sep 3, 2026 | Endovascular Engineering | Helo Max Thrombectomy System (HEL2090) | K261800 |
| Sep 3, 2026 | MicroVention, Inc., d/b/a Terumo Neuro | Mayumi Thrombectomy System | K254035 |
| Sep 3, 2026 | Happy Health, Inc. | Happy Health Blood Pressure Monitor | K254000 |
| Aug 31, 2026 | Evolym, LLC | Aerloom | K254217 |
| Aug 28, 2026 | Medtronic, Inc. | LINQ II Insertable Cardiac Monitor (ICM) (LNQ22) | K262735 |
| Aug 28, 2026 | Reflow Medical, Inc. | Kiba CTO Crossing Catheter | K262013 |
| Aug 28, 2026 | Imperative Care, Inc. | Zoom 4S Catheter | K261176 |
| Aug 27, 2026 | Stereotaxis, Inc. | GenesisX RMN | K262744 |
| Aug 27, 2026 | Piraeus Medical, Inc. | 35 Helix Guidewire | K260751 |
| Aug 24, 2026 | Bolt Medical, Inc. | SEISMIQ Intravascular Lithotripsy System | K260246 |
| Aug 21, 2026 | Inari Medical, Inc. | Artix MT;Artix Thin-Walled Sheath | K262538 |
| Aug 21, 2026 | Medtronic, Inc. | Affera Integrated Mapping System | K262005 |
| Aug 21, 2026 | Tempus AI, Inc. | Tempus ECG-PH | K253699 |
| Aug 21, 2026 | Boston Scientific | AVVIGO+ Multi-Modality Guidance System | K253692 |
| Aug 20, 2026 | Draeger Medical Systems, Inc. | Infinity Acute Care System (IACS) VG8.1 | K260579 |
| Aug 18, 2026 | Wallaby Medical | p17 XR Microcatheter | K254071 |
| Aug 14, 2026 | Arbor Endovascular, LLC | Willow 12 Guidewire | K262424 |
| Aug 14, 2026 | Infinium Medical, Inc. | Vital Signs Monitor (CLEO2) | K260438 |
| Aug 13, 2026 | CERENOVUS, Inc. | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set | K262398 |
| Aug 13, 2026 | Wellvii, Inc. | BP Go (BPP-855) | K261061 |
| Aug 13, 2026 | Hill-Rom, Inc. | Dashboard (P007000) | K260211 |
| Aug 12, 2026 | Alembic, LLC | APRO 35 Swift Catheter | K262392 |
| Aug 12, 2026 | Alembic, LLC | APRO 35 Swift Catheter and Alembic Aspiration Tubing | K262391 |
| Aug 12, 2026 | Masimo Corporation | Masimo Root Monitoring System | K253417 |
| Aug 6, 2026 | Scientia Vascular, Inc. | Aristotle Mini Guidewire | K260223 |
| Aug 4, 2026 | Jupiter Endovascular | Vertex Thrombectomy System | K261523 |
| Aug 3, 2026 | ACIST Medical Systems, Inc. | VueJect Ultrasound Enhancing Agent Delivery System | K262115 |
- Oct 30, 2026Medivance, Inc.
Arctic Sun Neonatal ArcticGel Pad
- Oct 30, 2026AngioDynamics, Inc.
AngioVac F1885
- Oct 30, 2026Cb Innovations, LLC
EXG PulseLinQ Cables (EXGPL)
- Oct 30, 2026Catheter Precision, Inc.
VIVO (9002)
- Oct 29, 2026Medtronic, Inc.
DLP Coronary Ostial Cannulae
- Oct 29, 2026Cleerly, Inc.
Cleerly ISCHEMIA
- Oct 28, 2026Lymphatech, Inc.
LymphaTech Mobile 3D Measuring Tool
- Oct 27, 2026Transonic Systems, Inc.
FlowXL System: FlowXL Flowmeter and compatible Flowprobes and Flowsensors
- Oct 27, 2026Tactile Medical
Nimbl Pneumatic Compression System
- Oct 26, 2026Expanse Medical, Inc.
FLOWRUNNER Aspiration System
- Oct 23, 2026Monebo Technologies, Inc.
Kinetic Software Library
- Oct 21, 2026Toro Neurovascular, Inc.
Toro 71 Aspiration Catheter; Toro Aspiration Tubing
- Oct 21, 2026Aventusoft, LLC
Hemotag Analysis Software (HAS)
- Oct 19, 2026Innovative Health, LLC
Reprocessed BRK Transseptal Needle
- Oct 16, 2026Route 92 Medical, Inc.
Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set
- Oct 16, 2026Analog Devices
Sensinel Cardiopulmonary Management (CPM) System
- Oct 15, 2026Penumbra, Inc.
INDIGO Aspiration System
- Oct 15, 2026Circadia Health, Inc.
The Circadia CX00 System (CX00)
- Oct 14, 2026Masimo Corporation
Radius VSM and Accessories
- Oct 9, 2026Stryker Neurovascular
Excelsior Reach Microcatheter
- Oct 7, 2026Ceiba Healthcare US, Inc.
eClinics
- Oct 6, 2026Okami Medical, Inc.
LOBO Vascular Occlusion System
- Oct 6, 2026Bayer Medical Care, Inc.
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD IS12 Module (IS12); MEDRAD Imaging Bulk Package Transfer Spike
- Oct 6, 2026Alembic, LLC
APRO 88 Catheter
- Oct 5, 2026HeartSciences, Inc.
MyoVista wavECG (DG-200-B15-003)
- Oct 2, 2026Cognition Medical Corp.
OAB Delivery Catheter
- Oct 1, 2026Centerline Biomedical
Intra-Operative Positioning System (IOPS) and IOPS Visionary System
- Sep 29, 2026Elucid Bioimaging, Inc.
Elucid FFR-IQ (B.1)
- Sep 29, 2026QT Medical, Inc.
QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)
- Sep 25, 2026Tempus AI, Inc.
Tempus ECG-MR
- Sep 25, 2026Life Detection Technologies
DistaSense(TM) (v1)
- Sep 21, 2026Trisalus Life Sciences
TriSalus TriNav Advance Infusion System
- Sep 18, 2026Vantis Vascular, Inc.
CrossFAST Integrated Microcatheter Advanced Delivery System
- Sep 18, 2026Epic Systems Corporation
Deterioration Index Version 2
- Sep 18, 2026Inari Medical, Inc.
Triever Duo Catheter
- Sep 17, 2026Abbott Medical
EnSite X EP System
- Sep 16, 2026Route 92 Medical, Inc.
Route 92 Medical Full Length 046 Access System
- Sep 16, 2026Scientia Vascular
Aristotle 65 Macrowire
- Sep 14, 2026Maduro Medical, Inc.
Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit
- Sep 11, 2026Bio Compression Systems, Inc.
Sequential Circulator (SC-4004-DL, SC-4008-DL)
- Sep 11, 2026Zbeats, Inc.
ZBPro Diagnostic (Version 2.0)
- Sep 10, 2026OMRON Healthcare, Inc.
Upper Arm Blood pressure monitor (BP7155D)
- Sep 10, 2026Siemens Medical Solutions USA, Inc.
ACUNAV Luxera 4D ICE Catheter
- Sep 10, 2026Procerus Enterprises
TruPress
- Sep 8, 2026Emboline, Inc.
Emboliner Embolic Protection System (EPC-03)
- Sep 4, 2026Piraeus Medical, Inc.
70 NeuGlide Catheter
- Sep 4, 2026Peerbridge Health, Inc.
Peerbridge COR MDx (Cor MDx)
- Sep 3, 2026Endovascular Engineering
Helo Max Thrombectomy System (HEL2090)
- Sep 3, 2026MicroVention, Inc., d/b/a Terumo Neuro
Mayumi Thrombectomy System
- Sep 3, 2026Happy Health, Inc.
Happy Health Blood Pressure Monitor
- Aug 31, 2026Evolym, LLC
Aerloom
- Aug 28, 2026Medtronic, Inc.
LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)
- Aug 28, 2026Reflow Medical, Inc.
Kiba CTO Crossing Catheter
- Aug 28, 2026Imperative Care, Inc.
Zoom 4S Catheter
- Aug 27, 2026Stereotaxis, Inc.
GenesisX RMN
- Aug 27, 2026Piraeus Medical, Inc.
35 Helix Guidewire
- Aug 24, 2026Bolt Medical, Inc.
SEISMIQ Intravascular Lithotripsy System
- Aug 21, 2026Inari Medical, Inc.
Artix MT;Artix Thin-Walled Sheath
- Aug 21, 2026Medtronic, Inc.
Affera Integrated Mapping System
- Aug 21, 2026Tempus AI, Inc.
Tempus ECG-PH
- Aug 21, 2026Boston Scientific
AVVIGO+ Multi-Modality Guidance System
- Aug 20, 2026Draeger Medical Systems, Inc.
Infinity Acute Care System (IACS) VG8.1
- Aug 18, 2026Wallaby Medical
p17 XR Microcatheter
- Aug 14, 2026Arbor Endovascular, LLC
Willow 12 Guidewire
- Aug 14, 2026Infinium Medical, Inc.
Vital Signs Monitor (CLEO2)
- Aug 13, 2026CERENOVUS, Inc.
CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set
- Aug 13, 2026Wellvii, Inc.
BP Go (BPP-855)
- Aug 13, 2026Hill-Rom, Inc.
Dashboard (P007000)
- Aug 12, 2026Alembic, LLC
APRO 35 Swift Catheter
- Aug 12, 2026Alembic, LLC
APRO 35 Swift Catheter and Alembic Aspiration Tubing
- Aug 12, 2026Masimo Corporation
Masimo Root Monitoring System
- Aug 6, 2026Scientia Vascular, Inc.
Aristotle Mini Guidewire
- Aug 4, 2026Jupiter Endovascular
Vertex Thrombectomy System
- Aug 3, 2026ACIST Medical Systems, Inc.
VueJect Ultrasound Enhancing Agent Delivery System
Source: FDA public records. The K number is in Whimbrel's corpus, and the company, device, state, product code and review panel are the openFDA 510(k) fields for that K number. FDA data through October 30, 2026. Each K number links to the FDA record. openFDA data are not validated by the FDA for medical decisions. Check the FDA record before you rely on a row. openFDA 510(k) API. FDA 510(k) database.
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