Home / 510(k) Clearances / K073672

510(k) K073672

SKATER BILIARY CATHETER by Angiotech — Product Code FGE

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

Other clearances by Angiotech

  • K151112 — Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design (September 10, 2015)
  • DEN090007 — BIO-SEAL LUNG BIOPSY TRACT SYSTEM (December 19, 2012)
  • K120827 — QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE) (July 13, 2012)
  • K113744 — QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE) (February 1, 2012)
  • K113800 — QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE (January 20, 2012)
  • K070610 — SKATER BILIARY CATHETER (June 21, 2007)

Other clearances for product code FGE

  • K253987 — BARE Wireguided Balloon Dilation Catheter (1235) (March 13, 2026)
  • K253132 — Single use stone retrieval balloons (March 6, 2026)
  • K251123 — Niti-S Biliary Stent; Niti-S Biliary Slim M Stent (December 29, 2025)
  • K251019 — BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G (December 22, 2025)
  • K250409 — Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disp (October 21, 2025)
  • K251229 — EndoFix™Tissue Fixation System (August 20, 2025)
  • K243412 — ARCHIMEDES Biodegradable Pancreatic Stent (July 16, 2025)
  • K251291 — Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery (July 3, 2025)
  • K242845 — EGIS Biliary Double Bare Stent (BDB080405) (June 25, 2025)
  • K241888 — Single-use Balloon Dilatation Catheter (December 20, 2024)