Submission Details
| 510(k) Number | K033714 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 26, 2003 |
| Decision Date | December 11, 2003 |
| Days to Decision | 15 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING
Dec 2003
Decision
15d
Days
Class 2
Risk
About This 510(k) Submission
K033714 is an FDA 510(k) clearance for the MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING, a Reservoir, Blood, Cardiopulmonary Bypass (Class II — Special Controls, product code DTN), submitted by Dideco S.P.A. (Waltham, US). The FDA issued a Cleared decision on December 11, 2003, 15 days after receiving the submission on November 26, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4400.
Device Classification
| Product Code | DTN — Reservoir, Blood, Cardiopulmonary Bypass |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4400 |
Manufacturer
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