The following data is part of a premarket notification filed by Dideco S.r.l. with the FDA for Performa Adult Hollow Fiber Membrane Oxygenator.
| Device ID | K050447 |
| 510k Number | K050447 |
| Device Name: | PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | DIDECO S.R.L. 195 WEST ST. Waltham, MA 02451 |
| Contact | Barry Sall |
| Correspondent | Barry Sall DIDECO S.R.L. 195 WEST ST. Waltham, MA 02451 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-22 |
| Decision Date | 2005-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178100718 | K050447 | 000 |
| 38033178100688 | K050447 | 000 |