The following data is part of a premarket notification filed by Medtronic Blood Management with the FDA for Autotransfusion Appartus (autolog).
| Device ID | K972894 |
| 510k Number | K972894 |
| Device Name: | AUTOTRANSFUSION APPARTUS (AUTOLOG) |
| Classification | Apparatus, Autotransfusion |
| Applicant | MEDTRONIC BLOOD MANAGEMENT 18501 EAST PLAZA DR. Parker, CO 80134 -9061 |
| Contact | Joyce Thomas |
| Correspondent | Joyce Thomas 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 | 1997-08-05 |
| Decision Date | 1998-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994776884 | K972894 | 000 |
| 00673978525150 | K972894 | 000 |
| 00673978525143 | K972894 | 000 |
| 00673978521930 | K972894 | 000 |
| 00673978521923 | K972894 | 000 |
| 00673978521916 | K972894 | 000 |
| 10673978521869 | K972894 | 000 |