The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs(r) Hi-torque Gold(tm) Guide Wire.
Device ID | K884262 |
510k Number | K884262 |
Device Name: | ACS(R) HI-TORQUE GOLD(TM) GUIDE WIRE |
Classification | Wire, Guide, Catheter |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. Temecula, CA 92591 |
Contact | Kevin Corrrigan |
Correspondent | Kevin Corrrigan 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 | 1988-10-11 |
Decision Date | 1988-12-21 |