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510(k) K855142

ANGIOMED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGTAPHY by Angiomed U.S., Inc. — Product Code FGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1986
Date Received
December 26, 1985
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

Other clearances by Angiomed U.S., Inc.

  • K874771 — ANGIOMED INTRODUCING SETS (January 12, 1988)
  • K874585 — ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE (December 2, 1987)
  • K864225 — ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT (January 30, 1987)
  • K863386 — VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS (October 24, 1986)
  • K862805 — ANGIOMED VAC-U-CUT BIOPSY NEEDLE (September 29, 1986)
  • K863446 — ANGIOMED HIGH PRESSURE CONNECTORS (September 23, 1986)
  • K854910 — ANGIOFLOW (July 17, 1986)
  • K854912 — ANGIOMED GUIED WIRES (April 16, 1986)
  • K854908 — UROFLEX (March 14, 1986)
  • K855143 — ANGIOMED EXCHANGE DRAINAGE CATHETER SETS (March 11, 1986)

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)