The following data is part of a premarket notification filed by Schneider Intl., Ltd. with the FDA for Schneider 8 Fr. Stamina(tm) Guiding Catheter.
| Device ID | K920157 |
| 510k Number | K920157 |
| Device Name: | SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER |
| Classification | Implantable Pacemaker Pulse-generator |
| 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 | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-14 |
| Decision Date | 1992-03-16 |