The following data is part of a premarket notification filed by Dideco S.p.a. with the FDA for Dideco Ats Autotransfusion Cardiotomy Reservoir.
| Device ID | K992599 |
| 510k Number | K992599 |
| Device Name: | DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | DIDECO S.P.A. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia J.m. Nolte |
| Correspondent | Cynthia J.m. Nolte DIDECO S.P.A. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-03 |
| Decision Date | 1999-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178105379 | K992599 | 000 |