Thoratec Switzerland GmbH

Address:TECHNOPARKSTRASSE 1,ZURICH,CH

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type (KFM) (6) ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS (KRI) (4)

Premarket Exempt

No Yes

Clear

CENTRIMAG® MEDICAL POWER CORD US / CANADA - 07640135140337 Catalog Number : 102964

Device Description : MEDICAL POWER CORD US / CANADA

Device Class : 2

Duns Number: 486066918

Premarket Exempt : No

Product Code : KFM

Prescription Use : Yes

Device Count : 1

CENTRIMAG™ TRAINING LOOP - 07640135140351 Catalog Number : 102963

Device Class : 2

Duns Number: 486066918

Premarket Exempt : No

Product Code : KFM

Prescription Use : Yes

Device Count : 1

TUBING BEND RELIEF - 07640135140399 Catalog Number : 201-50126

Device Class :

Duns Number: 486066918

Premarket Exempt : No

Product Code : KFM

Prescription Use : Yes

Device Count : 10

METAL LOCKING FEATURE FOR CENTRIMAG MOTOR - 07640135140405 Catalog Number : 104326

Device Class : 2

Duns Number: 486066918

Premarket Exempt : No

Product Code : KFM

Prescription Use : Yes

Device Count : 1

CentriMag™ - 07640135140412 Catalog Number : 201-50128

Device Description : Pressure Cable for Bbraun Combitrans Pressure Transducers

Device Class : 1

Duns Number: 486066918

Premarket Exempt : Yes

Product Code : KRI

Prescription Use : No

Device Count : 1

CentriMag™ - 07640135140429 Catalog Number : 201-50129

Device Description : Pressure Cable for Smiths Medical TranStar Pressure Sensors

Device Class : 1

Duns Number: 486066918

Premarket Exempt : Yes

Product Code : KRI

Prescription Use : No

Device Count : 1

CentriMag™ - 07640135140436 Catalog Number : 201-50130

Device Description : Pressure Cable for Smiths Medical LogiCal Plus Pressure Sensors

Device Class : 1

Duns Number: 486066918

Premarket Exempt : Yes

Product Code : KRI

Prescription Use : No

Device Count : 1

CentriMag™ - 07640135140443 Catalog Number : 201-50131

Device Description : Pressure cable for Biosensors' Accutrans and Utah Medical's Deltran II DPT-248 P Pressure cable for Biosensors' Accutrans and Utah Medical's Deltran II DPT-248 Pressure Sensors

Device Class : 1

Duns Number: 486066918

Premarket Exempt : Yes

Product Code : KRI

Prescription Use : No

Device Count : 1

PEDIATRIC TRAINING LOOP - 07640135140467 Catalog Number : 201-50134

Device Class : 2

Duns Number: 486066918

Premarket Exempt : No

Product Code : KFM

Prescription Use : Yes

Device Count : 1

CENTRIMAG MOTOR BRACKET (45 DEGREE) - 07640135140474 Catalog Number : 102961

Device Class : 2

Duns Number: 486066918

Premarket Exempt : No

Product Code : KFM

Prescription Use : Yes

Device Count : 1

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