510(k) K063238

ULTRACLIP II WING AND ULTRACLIP II COIL by Inrad — Product Code NEU

K063238 is an FDA 510(k) premarket notification submitted by Inrad for the device "ULTRACLIP II WING AND ULTRACLIP II COIL". The FDA issued a decision of Substantially Equivalent on January 30, 2007. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Inrad has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2007
Date Received
October 26, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Marker, Radiographic, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type