The following data is part of a premarket notification filed by Cardiovention, Inc. with the FDA for Cardiovention Corx Ios-200 System, Model Ios-200.
| Device ID | K032068 |
| 510k Number | K032068 |
| Device Name: | CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200 |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| 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 | DTR |
| Subsequent Product Code | DTP |
| Subsequent Product Code | DTZ |
| Subsequent Product Code | KFM |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-03 |
| Decision Date | 2003-08-22 |
| Summary: | summary |