The following data is part of a premarket notification filed by Dideco S.r.l. with the FDA for D 905 Eos Hollow Fiber Oxygenator With Integrated Hardshell Venous/cardiotomy Reservoir.
| Device ID | K043323 |
| 510k Number | K043323 |
| Device Name: | D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-02 |
| Decision Date | 2005-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178100237 | K043323 | 000 |
| 38033178100213 | K043323 | 000 |