The following data is part of a premarket notification filed by Dideco S.p.a. with the FDA for Apex Ph.i.s.i.o. Adult Hollow Fiber Membrane Oxygenator.
| Device ID | K020997 |
| 510k Number | K020997 |
| Device Name: | APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | DIDECO S.P.A. 195 WEST ST. Waltham, MA 02451 -1163 |
| Contact | Barry Sall |
| Correspondent | Barry Sall DIDECO S.P.A. 195 WEST ST. Waltham, MA 02451 -1163 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-28 |
| Decision Date | 2002-04-04 |
| Summary: | summary |