The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed Sidewinder Tuohy-borst Y-adapter.
| Device ID | K921577 |
| 510k Number | K921577 |
| Device Name: | SCIMED SIDEWINDER TUOHY-BORST Y-ADAPTER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | SCIMED LIFE SYSTEMS, INC. 6655 WEDGWOOD RD. Maple Grove, MN 55369 |
| Contact | Mercedes P Bayani |
| Correspondent | Mercedes P Bayani SCIMED LIFE SYSTEMS, INC. 6655 WEDGWOOD RD. Maple Grove, MN 55369 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-02 |
| Decision Date | 1992-10-16 |