The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Hi-torque Iron Man Guide Wire.
| Device ID | K963702 |
| 510k Number | K963702 |
| Device Name: | ACS HI-TORQUE IRON MAN GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. Santa Clara, CA 95052 -8167 |
| Contact | Kevin Corrigan |
| Correspondent | Kevin Corrigan ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. Santa Clara, CA 95052 -8167 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-16 |
| Decision Date | 1997-01-22 |
| Summary: | summary |