K201642 is an FDA 510(k) clearance for the Paragon Adult Maxi PMP Oxygenator with Tubing Pack. 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 September 18, 2020, 93 days after receiving the submission on June 17, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4350.
| 510(k) Number | K201642 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2020 |
| Decision Date | September 18, 2020 |
| Days to Decision | 93 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 |