The following data is part of a premarket notification filed by Cardiovention, Inc. with the FDA for Modification To Cardiovention Powerbase Console, Model Pcb-100.
| Device ID | K030141 |
| 510k Number | K030141 |
| Device Name: | MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100 |
| Classification | Console, Heart-lung Machine, 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 | DTQ |
| CFR Regulation Number | 870.4220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-15 |
| Decision Date | 2003-02-26 |
| Summary: | summary |