The following data is part of a premarket notification filed by Cardiovention, Inc. with the FDA for Cardiovention Corx System, Model Fg 0001.
| Device ID | K012325 |
| 510k Number | K012325 |
| Device Name: | CARDIOVENTION CORX SYSTEM, MODEL FG 0001 |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | CARDIOVENTION, INC. 3045 STENDER WAY Santa Clara, CA 95054 |
| Contact | Tessa Yamut |
| Correspondent | Tessa Yamut CARDIOVENTION, INC. 3045 STENDER WAY Santa Clara, CA 95054 |
| Product Code | KFM |
| Subsequent Product Code | DTP |
| Subsequent Product Code | DTZ |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-23 |
| Decision Date | 2002-04-09 |
| Summary: | summary |