Submission Details
| 510(k) Number | K031776 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 10, 2003 |
| Decision Date | July 25, 2003 |
| Days to Decision | 45 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
K031776 is an FDA 510(k) clearance for the MC2X MULTI-STAGE VENOUS CANNULA, a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by Medtronic Perfusion Systems (Minneapolis, US). The FDA issued a Cleared decision on July 25, 2003, 45 days after receiving the submission on June 10, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.
| 510(k) Number | K031776 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 10, 2003 |
| Decision Date | July 25, 2003 |
| Days to Decision | 45 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 |