The following data is part of a premarket notification filed by Dideco S.p.a. with the FDA for D 903 Avant Adult Hollow Fiber Oxygenator And D 903 Avant 2 Ph.i.s.i.o. Adult Hollow Fiber Oxygenator With Coating.
| Device ID | K033323 |
| 510k Number | K033323 |
| Device Name: | D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-15 |
| Decision Date | 2004-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178100473 | K033323 | 000 |
| 38033178100169 | K033323 | 000 |
| 38033178100107 | K033323 | 000 |