The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed(r) 0.038 Controlwire(tm) Peripher Guide Wir.
| Device ID | K926457 |
| 510k Number | K926457 |
| Device Name: | SCIMED(R) 0.038 CONTROLWIRE(TM) PERIPHER GUIDE WIR |
| Classification | Wire, Guide, Catheter |
| Applicant | SCIMED LIFE SYSTEMS, INC. 2905 NORTHWEST BLVD. SUITE 60 Plymouth, MN 55441 |
| Contact | Darlene A Thometz |
| Correspondent | Darlene A Thometz SCIMED LIFE SYSTEMS, INC. 2905 NORTHWEST BLVD. SUITE 60 Plymouth, MN 55441 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-24 |
| Decision Date | 1993-04-08 |