The following data is part of a premarket notification filed by Medtronic Blood Management with the FDA for Modification Of Autotransfusion Apparatus (autolog).
| Device ID | K982755 |
| 510k Number | K982755 |
| Device Name: | MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG) |
| Classification | Apparatus, Autotransfusion |
| Applicant | MEDTRONIC BLOOD MANAGEMENT 18501 EAST PLAZA DR. Parker, CO 80134 -9061 |
| Contact | Stephen Mckelvey |
| Correspondent | Stephen Mckelvey MEDTRONIC BLOOD MANAGEMENT 18501 EAST PLAZA DR. Parker, CO 80134 -9061 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-29 |
| Decision Date | 1998-08-20 |
| Summary: | summary |