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 |