The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Indeflator (modification).
| Device ID | K854310 |
| 510k Number | K854310 |
| Device Name: | ACS INDEFLATOR (MODIFICATION) |
| Classification | Injector And Syringe, Angiographic |
| Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View, CA 94043 |
| Contact | Marianna Breschini |
| Correspondent | Marianna Breschini ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View, CA 94043 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-24 |
| Decision Date | 1985-12-04 |