510(k) K926457

SCIMED(R) 0.038 CONTROLWIRE(TM) PERIPHER GUIDE WIR by Scimed Life Systems, Inc. — Product Code DQX

K926457 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "SCIMED(R) 0.038 CONTROLWIRE(TM) PERIPHER GUIDE WIR". The FDA issued a decision of Substantially Equivalent on Apr 8, 1993. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Scimed Life Systems, Inc. has 108 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 8, 1993
Date Received
Dec 24, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type
510(k)

Source: FDA 510(k) database entry for K926457. Report a data issue: hello@regdatalab.com.