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 |