The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Pleur-evac Cardiotomy Reservoir # Cr-9400 & 9400f.
| Device ID | K926338 |
| 510k Number | K926338 |
| Device Name: | PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F |
| Classification | Apparatus, Autotransfusion |
| Applicant | DEKNATEL, INC. KILOMETER 9 CARRETERA San Jose-heredia, CR |
| Contact | Harry Savard |
| Correspondent | Harry Savard DEKNATEL, INC. KILOMETER 9 CARRETERA San Jose-heredia, CR |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-18 |
| Decision Date | 1994-07-26 |