K191246 is an FDA 510(k) clearance for the Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP). This device is classified as a Oxygenator, Cardiopulmonary Bypass (Class II - Special Controls, product code DTZ).
Submitted by Chalice Medical , Ltd. (Worksop, GB). The FDA issued a Cleared decision on February 28, 2020, 295 days after receiving the submission on May 9, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4350.
| 510(k) Number | K191246 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2019 |
| Decision Date | February 28, 2020 |
| Days to Decision | 295 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 |