The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Bio-medicus Life Support Catheter And Introducer.
Device ID | K201100 |
510k Number | K201100 |
Device Name: | Bio-Medicus Life Support Catheter And Introducer |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | Medtronic Inc. 8200 Coral Sea St. NE Mounds Views, MN 55112 |
Contact | Juli Rubin |
Correspondent | Juli Rubin Medtronic Inc. 8200 Coral Sea St. NE Mounds Views, MN 55112 |
Product Code | DWF |
CFR Regulation Number | 870.4210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-04-24 |
Decision Date | 2021-07-15 |