Webster Diagnostic Deflectable Tip Catheter, Model D-1078

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

Full name

Cordis Webster Diagnostic Deflectable Tip Catheter, Model D-1078

510(k) Number

K991531 ↗

FDA Product Code

DRF

Device Class

Class II

Regulation

21 CFR Part 870.1220

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

• Cordis Webster Preface Braided Guiding Sheath & Perry Exchange Dilator, Model #'s 301-803A, 301-803P, 301-803M, 301-813S

  Class II

  FDA 510(k) K982740 Active Cleared 28 Aug 1998

See all devices from Cordis Webster, Inc. →

• What is the Webster Diagnostic Deflectable Tip Catheter (Model D-1078) used for?

  The Webster Diagnostic Deflectable Tip Catheter, Model D-1078, is specifically designed for intracardiac electrophysiological mapping. Its deflectable tip allows for precise navigation within cardiac chambers, enabling clinicians to stimulate and record electrical activity. This aids in assessing cardiac structures and localizing arrhythmias during electrophysiological studies.

• Is the Webster Diagnostic Deflectable Tip Catheter (Model D-1078) intended for single-use or reuse?

  The Webster Diagnostic Deflectable Tip Catheter, Model D-1078, is intended for single-use in electrophysiological laboratories and cardiac electrophysiology procedures. This design ensures patient safety and sterility for each procedure.

• How is the Webster Diagnostic Deflectable Tip Catheter (Model D-1078) supplied?

  The catheter is supplied sterile, ready for immediate use in diagnostic electrophysiological studies. Sterility is critical for maintaining patient safety during invasive procedures.

• What regulatory pathway does the Webster Diagnostic Deflectable Tip Catheter (Model D-1078) follow?

  The Webster Diagnostic Deflectable Tip Catheter, Model D-1078, is classified as a Class II medical device under FDA regulation 870.1220. It has received FDA 510(k) clearance (K991531) as substantially equivalent to a predicate device, confirming its compliance with U.S. regulatory standards for diagnostic catheters.

• Are there any specific storage conditions mentioned for the Webster Diagnostic Deflectable Tip Catheter (Model D-1078)?

  The regulatory submission for the Webster Diagnostic Deflectable Tip Catheter, Model D-1078, does not detail specific storage conditions. Clinicians should follow standard protocols for sterile medical devices to ensure optimal performance and sterility until use.