HeartMate 3™ Left Ventricular Assist System
Thoratec Corporation
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008792657 | 3008792657 | Thoratec Corporation | 1 | Y | 2026-01-01 | 4550 Norris Canyon Rd San Ramon CA US 94583 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 07640135140276 | CentriMag™ - Pressure Cable for BD DTX Plus Transducer | +1(855)478-5833 | customerservice@sjm.com |
| 07640135140283 | CentriMag™ - Motor Bracket | +1(855)478-5833 | customerservice@sjm.com |
| 07640135140412 | CentriMag™ - Pressure Cable for Bbraun Combitrans Pressure Transducers | +1(855)478-5833 | customerservice@sjm.com |
| 07640135140429 | CentriMag™ - Pressure Cable for Smiths Medical TranStar Pressure Sensors | +1(855)478-5833 | customerservice@sjm.com |
| 07640135140436 | CentriMag™ - Pressure Cable for Smiths Medical LogiCal Plus Pressure Sensors | +1(855)478-5833 | customerservice@sjm.com |
| 07640135140443 | CentriMag™ - Pressure cable for Biosensors' Accutrans and Utah Medical's Deltran II DPT-248 Pressure Sensors | +1(855)478-5833 | customerservice@sjm.com |
| 07640135140481 | CentriMag™ - Pressure Cable for Argon Medical CDX III Pressure Transducers | +1(855)478-5833 | customerservice@sjm.com |
| 07640135140566 | CentriMag™ - Mag Log Converter Software | +1(855)478-5833 | customerservice@sjm.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 216571 | 1169765554 | P870072 | THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM | DSQ | 1995-12-20 |
| 216571 | 1268771950 | P170038 | CentriMag Circulatory Support System | DSQ | 2019-12-06 |
| 216571 | 1693005481 | P160054 | HeartMate 3™ Left Ventricular Assist System | DSQ | 2017-08-23 |
| 216571 | 1548003494 | P100045 | CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM | MOM | 2014-05-28 |
| 216571 | 1150101011 | P060040 | THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM | DSQ | 2008-04-21 |
| 216571 | 2072640974 | K102129 | LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR | DWA | 2010-08-27 |
| 216571 | 1486203148 | K020271 | LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100 | KFM | 2003-03-25 |
| 216571 | 1650522540 | K001927 | VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME | DSY | 2000-12-18 |
| 216571 | 1305888222 | K001926 | VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES | DYB | 2000-09-22 |
| 216571 | 1850234297 | H070004 |
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
Thoratec Corporation
THORATEC CORPORATION
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