The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Affinity Cp Centrifugal Blood Pump With Or Without Coating, Affinity Cp Adapter.
| Device ID | K132712 |
| 510k Number | K132712 |
| Device Name: | AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2013-08-29 |
| Decision Date | 2013-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169855216 | K132712 | 000 |
| 20763000134550 | K132712 | 000 |
| 20763000134567 | K132712 | 000 |
| 00763000301323 | K132712 | 000 |
| 00643169272248 | K132712 | 000 |
| 20643169433230 | K132712 | 000 |
| 20643169433247 | K132712 | 000 |
| 20643169433254 | K132712 | 000 |
| 20643169785780 | K132712 | 000 |
| 20763000074412 | K132712 | 000 |
| 00643169272231 | K132712 | 000 |
| 20643169855193 | K132712 | 000 |
| 20643169855209 | K132712 | 000 |
| 20763000134536 | K132712 | 000 |