The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Bio-medicus Multi-stage Venous Femoral Percutaneous Kit.
| Device ID | K052524 |
| 510k Number | K052524 |
| Device Name: | BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038 |
| Contact | Bruce Backlund |
| Correspondent | Bruce Backlund MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-09-14 |
| Decision Date | 2005-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169086371 | K052524 | 000 |
| 00643169086364 | K052524 | 000 |
| 00643169086357 | K052524 | 000 |
| 00763000242367 | K052524 | 000 |
| 00763000242350 | K052524 | 000 |
| 00763000242343 | K052524 | 000 |