The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Bio-medicus Adult Cannulae Kit.
| Device ID | K180456 |
| 510k Number | K180456 |
| Device Name: | Bio-Medicus Adult Cannulae 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 | 2018-02-20 |
| Decision Date | 2018-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000116187 | K180456 | 000 |
| 00763000060527 | K180456 | 000 |
| 00763000060534 | K180456 | 000 |
| 00763000060541 | K180456 | 000 |
| 00763000060558 | K180456 | 000 |
| 00763000060565 | K180456 | 000 |
| 00763000116132 | K180456 | 000 |
| 00763000116149 | K180456 | 000 |
| 00763000116156 | K180456 | 000 |
| 00763000116163 | K180456 | 000 |
| 00763000116170 | K180456 | 000 |
| 00763000060572 | K180456 | 000 |