The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Affinity Cp Centrifugal Pump, Resting Heart Sys.,myotherm Cardioplegia Deliv.,affinity Hollow Fiber Oxygenator,aaf.
| Device ID | K111972 |
| 510k Number | K111972 |
| Device Name: | AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Contact | Jessica Sixberry |
| Correspondent | Jessica Sixberry MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Product Code | KFM |
| Subsequent Product Code | DPT |
| Subsequent Product Code | DRY |
| Subsequent Product Code | DTL |
| Subsequent Product Code | DTM |
| Subsequent Product Code | DTN |
| Subsequent Product Code | DTR |
| Subsequent Product Code | DTZ |
| Subsequent Product Code | DWF |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2011-07-11 |
| Decision Date | 2011-07-27 |
| Summary: | summary |