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510(k) K070610

SKATER BILIARY CATHETER by Angiotech — Product Code FGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2007
Date Received
March 5, 2007
Clearance Type
Traditional
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

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  • K113744 — QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE) (February 1, 2012)
  • K113800 — QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE (January 20, 2012)
  • K073672 — SKATER BILIARY CATHETER (January 24, 2008)

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