K120780 is an FDA 510(k) clearance for the EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE. This device is classified as a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II - Special Controls, product code DWF).
Submitted by Edwards Lifesciences, LLC (Draper, US). The FDA issued a Cleared decision on June 27, 2012, 105 days after receiving the submission on March 14, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4210.
| 510(k) Number | K120780 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 2012 |
| Decision Date | June 27, 2012 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| 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 |