DSQ · Ventricular (Assist) Bypass
· Class 3
Overview
| Product Code | DSQ |
|---|---|
| Device Name | Ventricular (Assist) Bypass |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
Identification
Approved pma: P870072
Recent Cleared Devices (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P170038 | CentriMag Circulatory Support System | Abbott | Dec 6, 2019 | APPR |
| P160054S008 | HeartMate 3 Left Ventricular Assist System | ABBOTT MEDICAL | Oct 18, 2018 | APPR |
| P100047S090 | HeartWare HVAD System | Medtronic | Sep 27, 2017 | APPR |
| P160054 | HeartMate 3 Left Ventricular Assist System | ABBOTT MEDICAL | Aug 23, 2017 | APPR |
| P160035 | EXCOR Pediatric Ventricular Assist Device | Berlin Heart, Inc. | Jun 6, 2017 | APPR |
| P100047 | HEARTWARE VENTRICULAR ASSIST SYSTEM | Medtronic | Nov 20, 2012 | APPR |
| P060040S005 | THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM | ABBOTT MEDICAL | Jan 20, 2010 | APPR |
| P060040 | THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM | ABBOTT MEDICAL | Apr 21, 2008 | APPR |
| P920014S016 | THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM (SNAP VE LVAS) | Thoratec Corp | Nov 6, 2002 | APPR |
| P980012 | NOVACOR LVAS | Worldheart, Inc. | Sep 29, 1998 | APWD |
| P920014S007 | HEARTMATE(R) VE LVAS | Thoratec Corp | Sep 29, 1998 | APPR |
| P870072S005 | THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM | Thoratec Laboratories Corp. | May 21, 1998 | APPR |
| P870072 | THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM | Thoratec Laboratories Corp. | Dec 20, 1995 | APWD |
| P920014 | HEARTMATE VE LVAS | Thoratec Corp | Sep 30, 1994 | APWD |
| P900023 | ABIOMED BVS(R) 5000 BI-VENTRICULAR SUPPORT SYSTEM | Abiomed Cardiovascular, Inc. | Nov 20, 1992 | APWD |
Top Applicants
- ABBOTT MEDICAL — 4 clearances
- Thoratec Corp — 3 clearances
- Medtronic — 2 clearances
- Thoratec Laboratories Corp. — 2 clearances
- Abbott — 1 clearance
