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 |