The following data is part of a premarket notification filed by Schneider Intl., Ltd. with the FDA for Magnum-meier Recanalization Guidewire.
| Device ID | K911547 |
| 510k Number | K911547 |
| Device Name: | MAGNUM-MEIER RECANALIZATION GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | SCHNEIDER INTL., LTD. 5905 NATHAN LN. Plymouth, MN 55442 |
| Contact | Howard B Wittels |
| Correspondent | Howard B Wittels 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 | 1991-04-08 |
| Decision Date | 1991-07-05 |