The following data is part of a premarket notification filed by Medtronic Inc with the FDA for Bio-medicus Adult Cannulae And Introducer.
| Device ID | K180453 |
| 510k Number | K180453 |
| Device Name: | Bio-Medicus Adult Cannulae And Introducer |
| 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 | 2018-02-20 |
| Decision Date | 2018-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000193522 | K180453 | 000 |
| 00763000060596 | K180453 | 000 |
| 00763000060602 | K180453 | 000 |
| 00763000060619 | K180453 | 000 |
| 00763000060626 | K180453 | 000 |
| 00763000060633 | K180453 | 000 |
| 00763000193492 | K180453 | 000 |
| 00763000193508 | K180453 | 000 |
| 00763000193515 | K180453 | 000 |
| 00763000060589 | K180453 | 000 |