The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Medtronic Bio-medicus Adult Cannula Kit.
| Device ID | K153598 |
| 510k Number | K153598 |
| Device Name: | Medtronic Bio-Medicus Adult Cannula Kit |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC INC. 8200 CORAL SEA STREET NE Mounds View, MN 55112 |
| Contact | Jennifer Tang |
| Correspondent | Jennifer Tang MEDTRONIC INC. 8200 CORAL SEA 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 | 2015-12-16 |
| Decision Date | 2016-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169026025 | K153598 | 000 |
| 00643169025684 | K153598 | 000 |
| 00643169025677 | K153598 | 000 |
| 00763000116200 | K153598 | 000 |
| 00763000116194 | K153598 | 000 |
| 00763000116064 | K153598 | 000 |
| 00763000116057 | K153598 | 000 |
| 00763000116040 | K153598 | 000 |
| 00763000116033 | K153598 | 000 |
| 00763000116026 | K153598 | 000 |
| 00643169025691 | K153598 | 000 |
| 00643169025707 | K153598 | 000 |
| 00643169026018 | K153598 | 000 |
| 00643169025844 | K153598 | 000 |
| 00643169025837 | K153598 | 000 |
| 00643169025820 | K153598 | 000 |
| 00643169025813 | K153598 | 000 |
| 00643169025806 | K153598 | 000 |
| 00643169025790 | K153598 | 000 |
| 00643169025721 | K153598 | 000 |
| 00643169025714 | K153598 | 000 |
| 00763000116019 | K153598 | 000 |