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 |