The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Affinity Cp Centrifugal Blood Pump With Balance Biosurface.
| Device ID | K111657 |
| 510k Number | K111657 |
| Device Name: | AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | MEDTRONIC, INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Contact | Lisa Stone |
| Correspondent | Lisa Stone MEDTRONIC, INC. 8200 Coral Sea Street 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 | 2011-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994647850 | K111657 | 000 |