The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Mc2x Multi-stage Venous Cannula, Models 91437, 91437c.
Device ID | K052372 |
510k Number | K052372 |
Device Name: | MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038 |
Contact | Ronald W Bennett |
Correspondent | Ronald W Bennett 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 | 2005-08-30 |
Decision Date | 2005-09-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00643169159280 | K052372 | 000 |
00643169159273 | K052372 | 000 |
20613994887058 | K052372 | 000 |
20613994887041 | K052372 | 000 |