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 |