The following data is part of a premarket notification filed by Schneider Intl., Ltd. with the FDA for Schneider Magnarail Probing Catheter.
| Device ID | K910259 |
| 510k Number | K910259 |
| Device Name: | SCHNEIDER MAGNARAIL PROBING CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | SCHNEIDER INTL., LTD. 5905 NATHAN LN. Plymouth, MN 55442 |
| Contact | Howard Wittels |
| Correspondent | Howard Wittels SCHNEIDER INTL., LTD. 5905 NATHAN LN. Plymouth, MN 55442 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-22 |
| Decision Date | 1991-04-18 |