The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Affinity Fusion Recirculation Line Model Rcl841.
| Device ID | K122913 |
| 510k Number | K122913 |
| Device Name: | AFFINITY FUSION RECIRCULATION LINE MODEL RCL841 |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Contact | Mary E Donlin |
| Correspondent | Mary E Donlin MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-21 |
| Decision Date | 2012-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169178025 | K122913 | 000 |