Avecor Cardiovascular, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 9
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K973760 | AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE | February 18, 1998 |
| K964017 | AFFINITY BLOOD PUMP SYSTEM | August 5, 1997 |
| K971105 | MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM | July 11, 1997 |
| K952532 | AFFINITY ARTERIAL BLOOD FILTER | October 6, 1995 |
| K940126 | AVECOR PRE-BYPASS FILTER | June 28, 1994 |
| K936003 | AFFINITY CVR | June 20, 1994 |
| K935717 | AFFINITY VENOUS RESERVIOR BAG | May 10, 1994 |
| K932252 | AFFINITY HOLLOW FIBER OXYGENATOR | November 19, 1993 |
| K924529 | SIGNATURE(TM) CUSTOM TUBING PACK | June 23, 1993 |