The following data is part of a premarket notification filed by Cardiovascular Devices, Inc. with the FDA for The Cdi(r) System 400.
| Device ID | K890113 |
| 510k Number | K890113 |
| Device Name: | THE CDI(R) SYSTEM 400 |
| Classification | Ion-exchange Chromatography |
| Applicant | CARDIOVASCULAR DEVICES, INC. 2801 BARRANCA Irvine, CA 92714 |
| Contact | Steven Arick |
| Correspondent | Steven Arick CARDIOVASCULAR DEVICES, INC. 2801 BARRANCA Irvine, CA 92714 |
| Product Code | DJY |
| CFR Regulation Number | 862.2230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-11 |
| Decision Date | 1989-05-23 |