The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for .10' Hi-torque Floppy, Inter. & Stand. Guide Wire.
| Device ID | K915723 |
| 510k Number | K915723 |
| Device Name: | .10' HI-TORQUE FLOPPY, INTER. & STAND. GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara, CA 95052 -8167 |
| Contact | Jane Beggs |
| Correspondent | Jane Beggs ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. P.O. BOX 58167 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 | 1991-12-20 |
| Decision Date | 1992-06-09 |