The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Acs Hi-torque All Star 0.014 Guide Wire With Microglide Coating.
| Device ID | K972142 |
| 510k Number | K972142 |
| Device Name: | ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATING |
| Classification | Wire, Guide, Catheter |
| Applicant | GUIDANT CORP. 26531 YNEZ RD. PO BOX 9810 Temecula, CA 92591 -4628 |
| Contact | Wayne R Hohman |
| Correspondent | Wayne R Hohman GUIDANT CORP. 26531 YNEZ RD. PO BOX 9810 Temecula, CA 92591 -4628 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-06 |
| Decision Date | 1997-08-25 |
| Summary: | summary |