The following data is part of a premarket notification filed by Schneider Intl., Ltd. with the FDA for Schneider Monorail(tm) Softrac-pta(tm) Catheter.
| Device ID | K902091 |
| 510k Number | K902091 |
| Device Name: | SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| 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 | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-09 |
| Decision Date | 1990-09-26 |