The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Autolog Autotransfusion System.
| Device ID | K093535 |
| 510k Number | K093535 |
| Device Name: | AUTOLOG AUTOTRANSFUSION SYSTEM |
| Classification | Apparatus, Autotransfusion |
| Applicant | MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Contact | Caralee Walton |
| Correspondent | Caralee Walton MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-16 |
| Decision Date | 2010-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994667694 | K093535 | 000 |
| 00613994667687 | K093535 | 000 |
| 00613994667670 | K093535 | 000 |
| 00613994520456 | K093535 | 000 |
| 00643169751644 | K093535 | 000 |
| 00643169266490 | K093535 | 000 |
| 00643169201347 | K093535 | 000 |