The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Bio-medicus Insertion Kit.
| Device ID | K190557 |
| 510k Number | K190557 |
| Device Name: | Bio-Medicus Insertion Kit |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | Medtronic, Inc. 8200 Coral Street NE Mounds View, MN 55112 |
| Contact | Huda Yusuf |
| Correspondent | Huda Yusuf Medtronic, Inc. 8200 Coral Street NE Mounds View, MN 55112 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-05 |
| Decision Date | 2019-04-03 |