The following data is part of a premarket notification filed by Schneider Intl., Ltd. with the FDA for Schneider Sidekick Monorail Y-connector.
| Device ID | K897082 |
| 510k Number | K897082 |
| Device Name: | SCHNEIDER SIDEKICK MONORAIL Y-CONNECTOR |
| Classification | Catheter, Percutaneous |
| Applicant | SCHNEIDER INTL., LTD. 2905 NORTHWEST BLVD. Minneapolis, MN 55441 |
| Contact | Robert L Ullen |
| Correspondent | Robert L Ullen SCHNEIDER INTL., LTD. 2905 NORTHWEST BLVD. Minneapolis, MN 55441 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-20 |
| Decision Date | 1990-03-06 |