K003724 is an FDA 510(k) clearance for the CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B. This device is classified as a Heat-exchanger, Cardiopulmonary Bypass (Class II - Special Controls, product code DTR).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on December 21, 2000, 17 days after receiving the submission on December 4, 2000.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4240.
| 510(k) Number | K003724 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 2000 |
| Decision Date | December 21, 2000 |
| Days to Decision | 17 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTR — Heat-exchanger, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4240 |