Company ยท US
Avecor Cardiovascular, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 1998. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 3 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 2 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 1 |
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 |
| KRJ | Filter, Prebypass, Cardiopulmonary Bypass | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 18, 1998 | K973760 | AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE Avecor Cardiovascular, Inc. | DTZ |
| Aug 5, 1997 | K964017 | AFFINITY BLOOD PUMP SYSTEM Avecor Cardiovascular, Inc. | DTQ |
| Jul 11, 1997 | K971105 | MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM Avecor Cardiovascular, Inc. | DTN |
| Oct 6, 1995 | K952532 | AFFINITY ARTERIAL BLOOD FILTER Avecor Cardiovascular, Inc. | DTM |
| Jun 28, 1994 | K940126 | AVECOR PRE-BYPASS FILTER Avecor Cardiovascular, Inc. | KRJ |
| Jun 20, 1994 | K936003 | AFFINITY CVR Avecor Cardiovascular, Inc. | DTN |
| May 10, 1994 | K935717 | AFFINITY VENOUS RESERVIOR BAG Avecor Cardiovascular, Inc. | DTN |
| Nov 19, 1993 | K932252 | AFFINITY HOLLOW FIBER OXYGENATOR Avecor Cardiovascular, Inc. | DTZ |
| Jun 23, 1993 | K924529 | SIGNATURE(TM) CUSTOM TUBING PACK Avecor Cardiovascular, Inc. | DWF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||