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 |