FDA.reportPublic FDA data

THORATEC CORP

Matched from indexed company URL: THORATEC CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12184441218444THORATEC CORP1N2026-01-0123 4th Ave BURLINGTON MA US 01803
29165962916596THORATEC CORP.1N2026-01-016035 Stoneridge Dr PLEASANTON CA US 94588
30087926573008792657Thoratec Corporation1Y2026-01-014550 Norris Canyon Rd San Ramon CA US 94583

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05415067038272HeartMate™ - ICU Cover+1(855)478-5833customerservice@sjm.com
05415067039422HeartMate 3™ - System Controller Low Flow 2.0+1(855)478-5833customerservice@sjm.com
05415067039606HeartMate™ - Travel Bag+1(855)478-5833customerservice@sjm.com
05415067039781HeartMate™ GoGear™ - Holster Vest Small+1(855)478-5833customerservice@sjm.com
05415067039842HeartMate™ GoGear™ - Consolidated Bag, Right+1(855)478-5833customerservice@sjm.com
05415067039866HeartMate™ GoGear™ - Battery Holster+1(855)478-5833customerservice@sjm.com
05415067039903HeartMate™ GoGear™ - Wearable Accessories Kit+1(855)478-5833customerservice@sjm.com
05415067039927HeartMate™ GoGear™ - Consolidated Bag, Left+1(855)478-5833customerservice@sjm.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2164141169765554P870072THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEMDSQ1995-12-20
2165711169765554P870072THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEMDSQ1995-12-20
2164151169765554P870072THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEMDSQ1995-12-20
2164151268771950P170038CentriMag Circulatory Support SystemDSQ2019-12-06
2164141268771950P170038CentriMag Circulatory Support SystemDSQ2019-12-06
2165711268771950P170038CentriMag Circulatory Support SystemDSQ2019-12-06
2164141693005481P160054HeartMate 3™ Left Ventricular Assist SystemDSQ2017-08-23
2165711693005481P160054HeartMate 3™ Left Ventricular Assist SystemDSQ2017-08-23
2164151693005481P160054HeartMate 3™ Left Ventricular Assist SystemDSQ2017-08-23
2164151548003494P100045CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEMMOM2014-05-28
2165711548003494P100045CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEMMOM2014-05-28
2164141150101011P060040THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEMDSQ2008-04-21
2165711150101011P060040THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEMDSQ2008-04-21
2164151150101011P060040THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEMDSQ2008-04-21
2164141507592993K234118CentriMag™ Acute Circulatory Support SystemQNR2024-01-26
2164151507592993K234118CentriMag™ Acute Circulatory Support SystemQNR2024-01-26
2164141807233330K222297CentriMag Pre-connected PackDTZ2022-12-01
2164151807233330K222297CentriMag Pre-connected PackDTZ2022-12-01
2164141542722552K222038CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support SystemQNR2022-12-08
2164151542722552K222038CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support SystemQNR2022-12-08
2165712072640974K102129LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITORDWA2010-08-27
2164142072640974K102129LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITORDWA2010-08-27
2164152072640974K102129LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITORDWA2010-08-27
2164141765813038K090051LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052KFM2009-10-08
2164151765813038K090051LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052KFM2009-10-08
2165711486203148K020271LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100KFM2003-03-25
2164151486203148K020271LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100KFM2003-03-25
2164141486203148K020271LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100KFM2003-03-25
2165711650522540K001927VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAMEDSY2000-12-18
2164151650522540K001927VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAMEDSY2000-12-18
2165711305888222K001926VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIESDYB2000-09-22
2164151305888222K001926VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIESDYB2000-09-22
2164151850234297H070004
2165711850234297H070004
2164141850234297H070004
2164151237972502
2164141237972502

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DSQ92017-08-23
KFM52009-10-08
QNR42024-01-26
DSQ 32019-12-06
DWA32010-08-27
DTZ22022-12-01
MOM22014-05-28
DSY22000-12-18
DYB22000-09-22

PMA#

197 records. Showing 1-40. Next

PMN#

GUDID#

200 records. Showing 1-40. Next