510(k) K073672

SKATER BILIARY CATHETER by Angiotech — Product Code FGE

K073672 is an FDA 510(k) premarket notification submitted by Angiotech for the device "SKATER BILIARY CATHETER". The FDA issued a decision of Substantially Equivalent on January 24, 2008. The device falls under product code FGE (Stents, Drains And Dilators For The Biliary Ducts), a Class II device regulated under 21 CFR 876.5010. Angiotech has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2008
Date Received
December 27, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stents, Drains And Dilators For The Biliary Ducts
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type