The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Dlp Aortic Root Cannula, Dlp Aortic Root Cannula With Vent Line, Dlp Pressure Monitoring Extension Line Adapter, Dlp Cardioplegia Adapter With Pressure Port.
| Device ID | K182586 |
| 510k Number | K182586 |
| Device Name: | DLP Aortic Root Cannula, DLP Aortic Root Cannula With Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter With Pressure Port |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | Medtronic, Inc. 8200 Coral Street NE Mounds View, MN 55125 |
| Contact | Linda L. Julia Davila |
| Correspondent | Linda L. Julia Davila Medtronic, Inc. 8200 Coral Street NE Mounds View, MN 55125 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-20 |
| Decision Date | 2018-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994918608 | K182586 | 000 |
| 20613994918585 | K182586 | 000 |
| 20613994900412 | K182586 | 000 |
| 20613994540090 | K182586 | 000 |
| 20613994495420 | K182586 | 000 |