The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Indeflator P/t 20.
Device ID | K883452 |
510k Number | K883452 |
Device Name: | ACS INDEFLATOR P/T 20 |
Classification | Injector And Syringe, Angiographic |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View, CA 94043 |
Contact | Kevyn B O'connor |
Correspondent | Kevyn B O'connor 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 | 1988-08-12 |
Decision Date | 1988-10-14 |