Cordis Webster Braided Guiding Sheath Exchange System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K970264 ↗

FDA Product Code

DYB

Device Class

Class II

Regulation

21 CFR Part 870.1340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cordis Wester Star Catheter

  Class II

  FDA 510(k) K954390 Active Cleared 21 Dec 1995

• Cordis Webster Ref-Star Ex Surface Reference Device Model's D-1204-01, -02, -03, and -04.

  Class II

  FDA 510(k) K980961 Active Cleared 28 May 1998

• Cordis Webster Fixed Curve Catheters, Models D-1124, D-1085

  Class II

  FDA 510(k) K992965 Active Cleared 26 Nov 1999

• Coridis Webster Deflectable Braided-Tip Electrode Catheter

  Class II

  FDA 510(k) K955817 Active Cleared 25 Mar 1996

• Cordis Webster Ref-Star External Reference Patch, Model # D-1210

  Class II

  FDA 510(k) K982415 Active Cleared 10 Aug 1998

• Webster Diagnostic Deflectable Tip Catheter, Model D-1078

  Class II

  FDA 510(k) K991531 Active Cleared 4 Oct 1999

See all devices from Cordis Webster, Inc. →

• What is the Cordis Webster Braided Guiding Sheath Exchange System used for?

  The system is designed to facilitate the exchange and placement of catheters within the vascular system, supporting vascular procedures by enabling sheath-based catheter manipulation through its guiding sheath components.

• What components are included in the Cordis Webster Braided Guiding Sheath Exchange System?

  The system includes guiding sheaths with sideport/valve, pre-shaped distal tip with radiopaque brite tip, guidewire, conventional vessel dilator, and long tapered exchange vessel dilator with multipurpose curve, all working together to support catheter exchange and navigation.

• What materials make up the sheath in the Cordis Webster Braided Guiding Sheath Exchange System?

  The sheath features a nylon body reinforced with stainless steel braid wire, incorporating transition segments of varying durometer that provide stiffness for cannulation and flexibility for navigation within the vascular system.

• What regulatory clearance does the Cordis Webster Braided Guiding Sheath Exchange System have?

  The device received FDA 510(k) clearance under K970264 and is classified under product code DYB, with a traditional clearance pathway and substantially equivalent determination based on its cardiovascular system use as indicated by advisory committee classification.