Company ยท US
Medtronic Blood Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 1995. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KRJ | Filter, Prebypass, Cardiopulmonary Bypass | 4 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 3 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 2 |
| LDF | Electrode, Pacemaker, Temporary | 2 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 1 |
| DWS | Instruments, Surgical, Cardiovascular | 1 |
| KRD | Device, Vascular, For Promoting Embolization | 1 |
| KRH | Ring, Annuloplasty | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 14, 1995 | K944966 | UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492 Medtronic Blood Systems, Inc. | LDF |
| Jul 14, 1995 | K944957 | TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500 Medtronic Blood Systems, Inc. | LDF |
| Dec 12, 1989 | K893207 | CLOSED CHEST SUPPORT CIRCUIT Medtronic Blood Systems, Inc. | DTZ |
| Nov 27, 1989 | K893678 | DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H Medtronic Blood Systems, Inc. | KRH |
| May 31, 1989 | K891687 | EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE Medtronic Blood Systems, Inc. | DTZ |
| May 19, 1989 | K891230 | MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV. Medtronic Blood Systems, Inc. | DTZ |
| Feb 22, 1989 | K885154 | INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM Medtronic Blood Systems, Inc. | KRJ |
| Dec 21, 1988 | K884390 | INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER Medtronic Blood Systems, Inc. | KRJ |
| Dec 5, 1988 | K884244 | INTERSEPT* PREBYPASS FILTER Medtronic Blood Systems, Inc. | KRJ |
| Oct 13, 1988 | K883439 | INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM Medtronic Blood Systems, Inc. | DTR |
| Sep 16, 1988 | K883086 | INTERSEPT*PREBYPASS FILTER Medtronic Blood Systems, Inc. | KRJ |
| Aug 12, 1988 | K882137 | EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40 Medtronic Blood Systems, Inc. | DTM |
| Aug 11, 1988 | K882136 | INTERSEPT* OXYGEN GAS LINE FILTER Medtronic Blood Systems, Inc. | KRD |
| Jul 18, 1988 | K882479 | 26MM DIAMETER HANCOCK* TROCAR BLADE AND TIP Medtronic Blood Systems, Inc. | DWS |
| May 6, 1988 | K880671 | MODIFIED INTERSEPT PEDIATRIC BLOOD FILTER Medtronic Blood Systems, Inc. | DTM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||