The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Malleable Single Stage Venous Cannula With Carmeda Bioactive Surface, Model Cb681xx Series.
Device ID | K033264 |
510k Number | K033264 |
Device Name: | MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038 |
Contact | Preeti Jain |
Correspondent | Preeti Jain 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 | No |
Date Received | 2003-10-09 |
Decision Date | 2003-10-31 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00643169697478 | K033264 | 000 |
00643169160019 | K033264 | 000 |
00643169160002 | K033264 | 000 |
00643169159990 | K033264 | 000 |
00643169159983 | K033264 | 000 |
00643169159976 | K033264 | 000 |
00643169158887 | K033264 | 000 |
00643169158870 | K033264 | 000 |
00643169158863 | K033264 | 000 |
00643169158856 | K033264 | 000 |
00763000192723 | K033264 | 000 |
00763000192716 | K033264 | 000 |
00763000192709 | K033264 | 000 |
00763000192693 | K033264 | 000 |
00763000192686 | K033264 | 000 |
00763000192679 | K033264 | 000 |
00763000192662 | K033264 | 000 |
00763000192655 | K033264 | 000 |
00643169160026 | K033264 | 000 |
00643169160033 | K033264 | 000 |
00643169160040 | K033264 | 000 |
00643169697461 | K033264 | 000 |
00643169697454 | K033264 | 000 |
00643169697447 | K033264 | 000 |
00643169697430 | K033264 | 000 |
00643169697423 | K033264 | 000 |
00643169697416 | K033264 | 000 |
00643169697409 | K033264 | 000 |
00643169697393 | K033264 | 000 |
00643169697386 | K033264 | 000 |
00643169697379 | K033264 | 000 |
00643169697362 | K033264 | 000 |
00643169697355 | K033264 | 000 |
00643169697348 | K033264 | 000 |
00643169697331 | K033264 | 000 |
00643169160156 | K033264 | 000 |
00643169160064 | K033264 | 000 |
00643169160057 | K033264 | 000 |
00763000192648 | K033264 | 000 |