THORATEC CORP.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2916596	2916596	THORATEC CORP.	1	N	2026-01-01	6035 Stoneridge Dr PLEASANTON CA US 94588

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
216415	1169765554	P870072	THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM	DSQ	1995-12-20
216415	1268771950	P170038	CentriMag Circulatory Support System	DSQ	2019-12-06
216415	1693005481	P160054	HeartMate 3™ Left Ventricular Assist System	DSQ	2017-08-23
216415	1548003494	P100045	CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM	MOM	2014-05-28
216415	1150101011	P060040	THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM	DSQ	2008-04-21
216415	1507592993	K234118	CentriMag™ Acute Circulatory Support System	QNR	2024-01-26
216415	1807233330	K222297	CentriMag Pre-connected Pack	DTZ	2022-12-01
216415	1542722552	K222038	CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System	QNR	2022-12-08
216415	2072640974	K102129	LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR	DWA	2010-08-27
216415	1765813038	K090051	LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052	KFM	2009-10-08
216415	1486203148	K020271	LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100	KFM	2003-03-25
216415	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
216415	1305888222	K001926	VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES	DYB	2000-09-22
216415	1850234297	H070004
216415	1237972502

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
DSQ	3	2017-08-23
QNR	2	2024-01-26
KFM	2	2009-10-08
DTZ	1	2022-12-01
DSQ	1	2019-12-06
MOM	1	2014-05-28
DWA	1	2010-08-27
DSY	1	2000-12-18
DYB	1	2000-09-22

PMA#

HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (HM II LVAS)
2014-08-05
THORATEC CORP.
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
2014-07-27
THORATEC CORP.
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM LVAS
2014-07-17
THORATEC CORP.
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
2014-05-06
THORATEC CORP.
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM LVAS
2014-04-09
THORATEC CORP.
HEARTMATE II LVAS
2014-04-03
THORATEC CORP.
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
2014-03-28
THORATEC CORP.
THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM DEVICE (LVAS)
2014-03-18
THORATEC CORP.
HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
2013-09-25
THORATEC CORP.
THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM (LVAS)
2013-08-05
THORATEC CORP.
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
2013-06-03
THORATEC CORP.
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
2013-06-03
THORATEC CORP.
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
2013-05-07
THORATEC CORP.
THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM DEVICE (LVAS)
2013-04-01
THORATEC CORP.
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
2012-10-05
THORATEC CORP.
THORATEC HEARTMATE II LVAS
2012-07-05
THORATEC CORP.
THORATEC HEART MATE II LEFT VENTRICULAR ASSIST SYSTEM
2012-06-22
THORATEC CORP.
THORATEC HEARTMATE II LVAS
2012-06-05
THORATEC CORP.
THORATEC HEARTMATE II LVAS
2012-06-05
THORATEC CORP.
THORATEC HEARTMATE II VAS
2012-05-31
THORATEC CORP.
HEARTMATE II VENTRICULAR ASSISTE SYSTEM
2012-05-17
THORATEC CORP.
HEARTMATE II LVAS
2012-03-29
THORATEC CORP.
HEARTMATE XVE LVAS
2011-12-21
THORATEC CORP.
HEARTMATE II LVAS
2011-12-21
THORATEC CORP.
THORATEC HEARTMATE II LVAS
2010-10-27
THORATEC CORP.
HEARTMATE II LVAS
2010-10-08
THORATEC CORP.
THORATEC HEARTMATE2 LVAS
2010-09-30
THORATEC CORP.
HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
2010-09-13
THORATEC CORP.
HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
2010-05-07
THORATEC CORP.
HEARTMATE II
2010-04-30
THORATEC CORP.
THORATEC HEARTMATE 2 LVAS
2010-04-19
THORATEC CORP.
THORATEC HEARTMATE 2 LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
2010-04-06
THORATEC CORP.
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
2010-01-20
THORATEC CORP.
THORATEC HEARTMATE II LVAS
2009-12-04
THORATEC CORP.
THORATEC HEARTMATE XVE LVAS
2009-03-13
THORATEC CORP.
THORATEC HEARTMATE II LVAS
2009-03-13
THORATEC CORP.
HEARTMATE II LVAS
2009-01-08
THORATEC CORP.
THORATEC HEARTMATE II LVAS
2008-12-03
THORATEC CORP.
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
2008-04-21
THORATEC CORP.
HEARTMATE XVE LEFT VENTRICULAR ASSIST SYSTEM
2007-06-29
THORATEC CORP.

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