K010974 is an FDA 510(k) clearance for the RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE STYLET. 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 June 18, 2001, 77 days after receiving the submission on April 2, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4210.
| 510(k) Number | K010974 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 2001 |
| Decision Date | June 18, 2001 |
| Days to Decision | 77 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 |