The following data is part of a premarket notification filed by Schneider Intl., Ltd. with the FDA for Schneider Magnum Peripheral Recanalization Guidewi.
| Device ID | K931577 |
| 510k Number | K931577 |
| Device Name: | SCHNEIDER MAGNUM PERIPHERAL RECANALIZATION GUIDEWI |
| Classification | Wire, Guide, Catheter |
| Applicant | SCHNEIDER INTL., LTD. 5905 NATHAN LN. Plymouth, MN 55442 |
| Contact | Amy Peterson |
| Correspondent | Amy Peterson 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 | 1993-03-30 |
| Decision Date | 1993-06-23 |