Medical Device Manufacturer · US , Plymouth , MN

Avecor Cardiovascular, Inc. - FDA 510(k) Cleared Devices

9 submissions · 8 cleared · Since 1993

Recent clearances: AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE, AFFINITY BLOOD PUMP SYSTEM, MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM

9

Total

8

Cleared

0

Denied

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

9 devices

1-9 of 9

Cleared Feb 18, 1998

AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE

Cardiovascular · 139d

Cleared Aug 05, 1997

AFFINITY BLOOD PUMP SYSTEM

Cardiovascular · 302d

Cleared Jul 11, 1997

MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM

Cardiovascular · 107d

Cleared Oct 06, 1995

AFFINITY ARTERIAL BLOOD FILTER

Cardiovascular · 127d

Cleared Jun 28, 1994

AVECOR PRE-BYPASS FILTER

Cardiovascular · 169d

Cleared Jun 20, 1994

Cardiovascular · 186d

Cleared May 10, 1994

AFFINITY VENOUS RESERVIOR BAG

Cardiovascular · 161d

Cleared Nov 19, 1993

AFFINITY HOLLOW FIBER OXYGENATOR

Cardiovascular · 177d

Cleared Jun 23, 1993

SIGNATURE(TM) CUSTOM TUBING PACK

Cardiovascular · 288d