K052372 is an FDA 510(k) clearance for the MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C. This device is classified as 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 September 22, 2005, 23 days after receiving the submission on August 30, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4210.
| 510(k) Number | K052372 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2005 |
| Decision Date | September 22, 2005 |
| Days to Decision | 23 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 |