The following data is part of a premarket notification filed by Schneider Intl., Ltd. with the FDA for Schneider Hydro-sil Guidewire.
| Device ID | K925804 |
| 510k Number | K925804 |
| Device Name: | SCHNEIDER HYDRO-SIL GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | SCHNEIDER INTL., LTD. 5905 NATHAN LN. Plymouth, MN 55442 |
| Contact | Robert L Ullen |
| Correspondent | Robert L Ullen SCHNEIDER INTL., LTD. 5905 NATHAN LN. Plymouth, MN 55442 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-16 |
| Decision Date | 1993-02-12 |