The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs 0.010 Hi-torque Floppy Gold Guide Wire.
| Device ID | K884895 |
| 510k Number | K884895 |
| Device Name: | ACS 0.010 HI-TORQUE FLOPPY GOLD GUIDE WIRE |
| 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 | 1988-11-22 |
| Decision Date | 1989-02-06 |