K182586 is an FDA 510(k) clearance for the DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port. This device is classified as a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II - Special Controls, product code DWF).
Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on October 19, 2018, 29 days after receiving the submission on September 20, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4210.
| 510(k) Number | K182586 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2018 |
| Decision Date | October 19, 2018 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4210 |