Panels › Cardiovascular
Cardiovascular devices
304 product codes reviewed by the Cardiovascular panel. 19,244 510(k) clearances and 6,943 recalls in the FDA data, 81% of those recalls name a 510(k).
415510(k)s in 12 months
469recalls in 12 months
5,607recalls that name a 510(k)
Active product codes, Class II
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| QAF | Impedance Plethysmograph, Cranial | 2 | 1 | 0 |
| QEX | Coronary Mechanical Thrombectomy With Aspiration | 2 | 1 | 0 |
| QHW | Single Lumen Ecmo Cannula | 2 | 1 | 0 |
| QJZ | Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure | 2 | 1 | 0 |
| QNL | Medium-Term Adjunctive Predictive Cardiovascular Indicator | 2 | 1 | 0 |
| QOK | Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate | 2 | 1 | 0 |
| QQI | Interventional Cardiovascular Implant Simulation Software Device | 2 | 1 | 0 |
| QUO | Adjunctive Heart Failure Status Indicator | 2 | 1 | 0 |
| QVQ | Extravascular Support For An Arteriovenous Fistula For Vascular Access | 2 | 1 | 0 |
| QXO | Cardiovascular Machine Learning-Based Notification Software | 2 | 1 | 0 |
| QXZ | Adjunctive Epicardial Vascular Physiologic Status Indicator | 2 | 1 | 0 |
| QYE | Reduced Ejection Fraction Machine Learning-Based Notification Software | 2 | 1 | 0 |
| QYX | Outpatient Cardiac Telemetry | 2 | 1 | 0 |
| SBQ | Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software | 2 | 1 | 0 |
| SCZ | Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures | 2 | 0 | 1 |
| SGO | Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures | 2 | 1 | 0 |
| SHP | Cardiac Amyloidosis Machine Learning-Based Notification Software | 2 | 1 | 0 |
| SHR | Device For Open Surgical Explant Of Endovascular Prostheses | 2 | 1 | 0 |
| SIF | Software Device System For Estimation Of Cardiac Pressures | 2 | 1 | 0 |
| SIU | Predictive Indicator For Long-Term Cardiovascular Outcomes | 2 | 1 | 0 |
| SJJ | Cardiac Device Identifier | 2 | 1 | 0 |
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