The following data is part of a premarket notification filed by Surgitek with the FDA for Hydrophilic Coated Guidewire.
| Device ID | K926344 |
| 510k Number | K926344 |
| Device Name: | HYDROPHILIC COATED GUIDEWIRE |
| Classification | Accessories, Catheter, G-u |
| Applicant | SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Contact | Brian Kunst |
| Correspondent | Brian Kunst SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Product Code | KNY |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-17 |
| Decision Date | 1993-03-05 |