510(k) K955293
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