K020997 is an FDA 510(k) clearance for the APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR. This device is classified as a Oxygenator, Cardiopulmonary Bypass (Class II - Special Controls, product code DTZ).
Submitted by Dideco S.P.A. (Waltham, US). The FDA issued a Cleared decision on April 4, 2002, 7 days after receiving the submission on March 28, 2002.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4350.
| 510(k) Number | K020997 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2002 |
| Decision Date | April 04, 2002 |
| Days to Decision | 7 days |
| Submission Type | Special |
| 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 |