Medical Device Manufacturer · US , Austin , TX

Sulzer Carbomedics, Inc. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1998

Recent clearances: SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR, PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sulzer Carbomedics, Inc. Cardiovascular ✕

8 devices

1-8 of 8

Cleared Dec 17, 2002

ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800

Cardiovascular · 84d

Cleared Jun 13, 2002

SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS

Cardiovascular · 279d

Cleared Apr 23, 2002

ANNULOFLO SYSTEM, MITRAL MODEL AR700

Cardiovascular · 22d

Cleared Jan 25, 2001

SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS

Cardiovascular · 206d

Cleared Dec 29, 1999

SULZER CARBOMEDICS CARDIOFIX PERICARDIUM

Cardiovascular · 89d

Cleared Oct 12, 1999

ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800

Cardiovascular · 116d

Cleared Aug 04, 1998

SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR

Cardiovascular · 235d

Cleared Apr 14, 1998

PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE

Cardiovascular · 307d