Medical Device Manufacturer · US , Austin , TX

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

8 submissions · 8 cleared · Since 1998

Recent clearances: ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800, SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS, ANNULOFLO SYSTEM, MITRAL MODEL AR700

View 8 510(k) Devices ↓

Total

Cleared

Denied

Sulzer Carbomedics, Inc. has 8 FDA 510(k) cleared medical devices. Based in Austin, US.

Historical record: 8 cleared submissions from 1998 to 2002. Primary specialty: Cardiovascular.

Browse the FDA 510(k) cleared devices submitted by Sulzer Carbomedics, Inc. Filter by specialty or product code using the sidebar.

Sulzer Carbomedics, Inc. is one of 21617 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

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

8 devices

1-8 of 8

Cleared Dec 17, 2002

ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800

K023185 · KRH

Cardiovascular · 84d

Cleared Jun 13, 2002

SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS

K013022 · DSY

Cardiovascular · 279d

Cleared Apr 23, 2002

ANNULOFLO SYSTEM, MITRAL MODEL AR700

K021051 · KRH

Cardiovascular · 22d

Cleared Jan 25, 2001

SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS

K002007 · DSY

Cardiovascular · 206d

Cleared Dec 29, 1999

SULZER CARBOMEDICS CARDIOFIX PERICARDIUM

K993288 · DXZ

Cardiovascular · 89d

Cleared Oct 12, 1999

ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800

K992056 · KRH

Cardiovascular · 116d

Cleared Aug 04, 1998

SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR

K974648 · MOP

Cardiovascular · 235d

Cleared Apr 14, 1998

PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE

K972201 · DXZ

Cardiovascular · 307d

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

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

Filters