The following data is part of a premarket notification filed by Dideco S.p.a. with the FDA for Apex Adult Hollowe Fiber Oxygenator.
| Device ID | K014080 |
| 510k Number | K014080 |
| Device Name: | APEX ADULT HOLLOWE FIBER OXYGENATOR |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | DIDECO S.P.A. 195 WEST ST. Waltham, MA 02451 -1163 |
| Contact | Barry S Sall |
| Correspondent | Barry S 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 | 2001-12-11 |
| Decision Date | 2002-01-08 |
| Summary: | summary |