The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Affinity Vard Sub-assembly For Cps (carmeda Coated), Purgeline (uncoated), Holding Bag.
| Device ID | K101186 |
| 510k Number | K101186 |
| Device Name: | AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG |
| Classification | Defoamer, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55432 |
| Contact | Caralee Walton |
| Correspondent | Caralee Walton MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55432 |
| Product Code | DTP |
| CFR Regulation Number | 870.4230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2010-04-28 |
| Decision Date | 2010-09-03 |