The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Hi-torque Floppy Guide Wire, 0.018 Inch.
| Device ID | K864585 |
| 510k Number | K864585 |
| Device Name: | ACS HI-TORQUE FLOPPY GUIDE WIRE, 0.018 INCH |
| Classification | Wire, Guide, Catheter |
| Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View, CA 94043 |
| Contact | Marianna Faist |
| Correspondent | Marianna Faist ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View, CA 94043 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-17 |
| Decision Date | 1986-12-05 |