Omnilink .035 Biliary Stent System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K053459 ↗

FDA Product Code

FGE

Device Class

Class II

Regulation

21 CFR Part 876.5010

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESU

• Acuity Steerable Stylet Accessory

  Class II

  FDA 510(k) K053019 Active Cleared 3 Mar 2006

• Rapido Cut-Away Bleedback Control Valve (Bbcv), Model 7568

  Class II

  FDA 510(k) K031903 Active Cleared 3 Mar 2004

• Modification to Rx Herculink 14 Biliary Stent System, Models 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13,

  Class II

  FDA 510(k) K993588 Active Cleared 17 Nov 1999

• Hi-Torque Balance Iniversal Guide Wire with Hydrocoat Hydrophilic Coating

  Class II

  FDA 510(k) K031678 Active Cleared 26 Aug 2003

• ACS Hi-Torque Cross IT 100XT, 200XT, and 300XT Guide Wires with Hydrocoat Hydrophilic Coating

  Class II

  FDA 510(k) K990639 Active Cleared 25 Mar 1999

• Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model Vh-3000 Open recall

  Class II

  FDA 510(k) K052274 Active Cleared 21 Sep 2005

See all devices from Guidant Corp. →