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Thoratec Corporation

USA · Pleasanton

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

11listed device types

Class I 1Class II 7Class III 2unclassified 1

plus 30 registration records and 3 510(k), 28 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

1 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

5active device licences

Class III 1Class IV 4

7 including historic records

TWTaiwanTFDA

2valid device licences

Class III 2

SGSingaporeHSA SMDR

1device registrations

CLASS D 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

23active ARTG entries

Class I 10Class III 10IIa 2IIb 1

HKHong KongMDACS

1valid listings

Class IV 1

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

1active registrations

Class 3 1

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States30 registration records, 3 510(k), 28 PMA, 4 excluded

Brazil0 confirmed, 1 excluded

Canada5 confirmed, 1 excluded

Manufacturer names merged into this page: Thoratec Corporation · THORATEC CORP. · THORATEC CORP · THORATEC CORPORATION

FDA 510(k) clearances by year

12013 · K131179

22015 · K152161

FDA listed device types

showing 8 of 11

System, Hemodynamic, Implantable 1Ventricular (Assist) Bypass 1Heat-Exchanger, Cardiopulmonary Bypass 1Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 1Control, Pump Speed, Cardiopulmonary Bypass 1Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type 1Console, Heart-Lung Machine, Cardiopulmonary Bypass 1Blood Pump For Ecmo, Long-Term (> 6 Hours) Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K152161	Thoratec CentriMag Return (Arterial) Cannula Kit	2015-09-18
US	K152190	Thoratec CentriMag Drainage (Venous) Cannula Kit	2015-09-18
US	K131179	CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR	2013-07-18
CA	1219	THORATEC VECTRA VASCULAR ACCESS GRAFT	Class III
CA	624	HEARTMATE IP LVAS (HEARTMATE IMPLANTABLE PNEUMATIC LEFT VENTRICULAR ASSIST SYSTEM)	Class IV
CA	715	HEARTMATE VE LVAS (HEARTMATE VENTED ELECTRIC LEFT VENTRICULAR ASSIST SYSTEM)	Class IV