The following data is part of a premarket notification filed by Schneider Intl., Ltd. with the FDA for Schneider Monorail-gex(tm) Guidewire Exchange Cath.
| Device ID | K902587 |
| 510k Number | K902587 |
| Device Name: | SCHNEIDER MONORAIL-GEX(TM) GUIDEWIRE EXCHANGE CATH |
| Classification | Catheter, Percutaneous |
| 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 | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-12 |
| Decision Date | 1990-12-03 |