The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Affinity Fusion Cardiotomy/venous Reservior With Balance Biosurface Model Bb841, Affinity Fusion Cardiotomy/ Venous Rese.
| Device ID | K122914 |
| 510k Number | K122914 |
| Device Name: | AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Contact | Julia A Nelson |
| Correspondent | Julia A Nelson MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2012-09-21 |
| Decision Date | 2013-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169178144 | K122914 | 000 |