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 |