K141492 is an FDA 510(k) clearance for the ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE). 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 6, 2015, 246 days after receiving the submission on June 5, 2014.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4350.
| 510(k) Number | K141492 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 2014 |
| Decision Date | February 06, 2015 |
| Days to Decision | 246 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 |