Medtronic Blood Systems, Inc.
Anaheim, CA, US
Medtronic Blood Systems, Inc. appears in FDA device records in Anaheim, CA. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Medtronic Blood Systems, Inc. between 1988 and 1995. The busiest year on record is 1988, with 8. The most recent is 1995, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 8 |
| 1989 | 5 |
| 1995 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K944966 | UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492 | LDF | Substantially Equivalent | |
| K944957 | TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500 | LDF | Substantially Equivalent | |
| K893207 | CLOSED CHEST SUPPORT CIRCUIT | DTZ | Substantially Equivalent | |
| K893678 | DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H | KRH | Substantially Equivalent | |
| K891687 | EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE | DTZ | Substantially Equivalent | |
| K891230 | MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV. | DTZ | Substantially Equivalent | |
| K885154 | INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM | KRJ | Substantially Equivalent | |
| K884390 | INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER | KRJ | Substantially Equivalent | |
| K884244 | INTERSEPT* PREBYPASS FILTER | KRJ | Substantially Equivalent | |
| K883439 | INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM | DTR | Substantially Equivalent | |
| K883086 | INTERSEPT*PREBYPASS FILTER | KRJ | Substantially Equivalent | |
| K882137 | EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40 | DTM | Substantially Equivalent | |
| K882136 | INTERSEPT* OXYGEN GAS LINE FILTER | KRD | Substantially Equivalent | |
| K882479 | 26MM DIAMETER HANCOCK* TROCAR BLADE AND TIP | DWS | Substantially Equivalent | |
| K880671 | MODIFIED INTERSEPT PEDIATRIC BLOOD FILTER | DTM | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KRDDevice, Vascular, For Promoting Embolization
- LDFElectrode, Pacemaker, Temporary
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line
- KRJFilter, Prebypass, Cardiopulmonary Bypass
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- DWSInstruments, Surgical, Cardiovascular
- DTZOxygenator, Cardiopulmonary Bypass
- KRHRing, Annuloplasty
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain