The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Hi-torque Standard & Intermedi. Guide Wire.
| Device ID | K881787 |
| 510k Number | K881787 |
| Device Name: | ACS HI-TORQUE STANDARD & INTERMEDI. GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| 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 | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-26 |
| Decision Date | 1988-07-25 |