K102109 is an FDA 510(k) clearance for the ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012. This device is classified as a Oxygenator, Cardiopulmonary Bypass (Class II - Special Controls, product code DTZ).
Submitted by Eurosets S.R.L (Medolla, Modena, IT). The FDA issued a Cleared decision on February 15, 2011, 202 days after receiving the submission on July 28, 2010.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4350.
| 510(k) Number | K102109 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 2010 |
| Decision Date | February 15, 2011 |
| Days to Decision | 202 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTZ - Oxygenator, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4350 |