The following data is part of a premarket notification filed by Guidcorp with the FDA for Hi-torque Pilot 50 Guide Wire With Hydrocoat Hydrophilic Coating, Hi-torque Pilot 150 Guide Wire With Hydrocoat Hydrophg.
| Device ID | K030549 |
| 510k Number | K030549 |
| Device Name: | HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE PILOT 150 GUIDE WIRE WITH HYDROCOAT HYDROPHG |
| Classification | Wire, Guide, Catheter |
| Applicant | GUIDCORP 26531 YNEZ RD. Temecula, CA 92591 |
| Contact | Stacey Brown |
| Correspondent | Stacey Brown GUIDCORP 26531 YNEZ RD. Temecula, CA 92591 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-21 |
| Decision Date | 2003-05-14 |
| Summary: | summary |