The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Advanced Cardiovascular Systems Angioject.
Device ID | K844045 |
510k Number | K844045 |
Device Name: | ADVANCED CARDIOVASCULAR SYSTEMS ANGIOJECT |
Classification | Injector And Syringe, Angiographic |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1500 SALADO DRIVE, SUITE 101 Mountain View, CA 04043 |
Contact | Jane E Beggs |
Correspondent | Jane E Beggs ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1500 SALADO DRIVE, SUITE 101 Mountain View, CA 04043 |
Product Code | DXT |
CFR Regulation Number | 870.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-17 |
Decision Date | 1984-11-13 |