K200612 is an FDA 510(k) clearance for the R501 aortic root cannula without vent line, R502 aortic root cannula with vent line. This device is classified as a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II - Special Controls, product code DWF).
Submitted by Sorin Group Italia S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on November 17, 2020, 253 days after receiving the submission on March 9, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4210.
| 510(k) Number | K200612 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 2020 |
| Decision Date | November 17, 2020 |
| Days to Decision | 253 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 |