510(k) K955293

FIBERED PLATINUM COIL, .035 TYPE by Target Therapeutics — Product Code KRD

K955293 is an FDA 510(k) premarket notification submitted by Target Therapeutics for the device "FIBERED PLATINUM COIL, .035 TYPE". The FDA issued a decision of Substantially Equivalent on February 6, 1996. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Target Therapeutics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1996
Date Received
November 16, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Vascular, For Promoting Embolization
Device Class
Class II
Regulation Number
870.3300
Review Panel
CV
Submission Type