The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Autolog Iq Autotransfusion System.
| Device ID | K181954 |
| 510k Number | K181954 |
| Device Name: | AutoLog IQ Autotransfusion System |
| Classification | Apparatus, Autotransfusion |
| Applicant | MEDTRONIC PERFUSION SYSTEMS 7611 Northland Drive Brooklyn Park, MN 55428 |
| Contact | Sue Fidler |
| Correspondent | Sue Fidler MEDTRONIC PERFUSION SYSTEMS 7611 Northland Drive Brooklyn Park, MN 55428 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-23 |
| Decision Date | 2018-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169982864 | K181954 | 000 |
| 00763000057503 | K181954 | 000 |
| 00763000057480 | K181954 | 000 |