The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Hi-torque Floppy/floppy Ii/inter./standard Gw.
Device ID | K881897 |
510k Number | K881897 |
Device Name: | ACS HI-TORQUE FLOPPY/FLOPPY II/INTER./STANDARD GW |
Classification | Wire, Guide, Catheter |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. Temecula, CA 92591 |
Contact | Gary Johnson |
Correspondent | Gary Johnson ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. Temecula, CA 92591 |
Product Code | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-06 |
Decision Date | 1988-08-03 |