The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Indeflator Plus (modification #2).
Device ID | K872981 |
510k Number | K872981 |
Device Name: | ACS INDEFLATOR PLUS (MODIFICATION #2) |
Classification | Injector And Syringe, Angiographic |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. Temecula, CA 92591 |
Contact | Kevin Corrigan |
Correspondent | Kevin Corrigan ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. Temecula, CA 92591 |
Product Code | DXT |
CFR Regulation Number | 870.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-31 |
Decision Date | 1987-10-20 |