Home / 510(k) Clearances / K040413

510(k) K040413

CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM by Cordis Europa, N.V. — Product Code FGE

Clearance Details

Decision
SESU ()
Decision Date
June 21, 2004
Date Received
February 18, 2004
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 Cordis Europa, N.V.

  • K071189 — CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER (May 16, 2007)
  • K063563 — CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATH (March 7, 2007)
  • K060302 — INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED (April 11, 2006)
  • K043605 — INSCOPE 3-STAGE BALLOON DILATOR (February 4, 2005)
  • K032737 — CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON (October 2, 2003)
  • K012056 — CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM (August 1, 2001)

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)