The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Affinity Cp Centrifugal Bllod Pump With Carmeda Bioactive Surface.
| Device ID | K111658 |
| 510k Number | K111658 |
| Device Name: | AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | MEDTRONIC INC. 8200 CORAL SEA ST NE Mounds View, MN 55112 |
| Contact | Lisa Stone |
| Correspondent | Lisa Stone MEDTRONIC INC. 8200 CORAL SEA ST NE Mounds View, MN 55112 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2011-06-14 |
| Decision Date | 2011-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994647867 | K111658 | 000 |