Stylet Introducer Funnel

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

510(k) Number

K854142 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Slimline Unipolar Endocardial Pacing Lead, 030-438

  Class III

  FDA 510(k) K865098 Active Cleared 18 Aug 1987

• Model 030-437 Implant Electrode

  Class III

  FDA 510(k) K870610 Active Cleared 20 Mar 1987

• Sterile Packaging

  Class III

  FDA 510(k) K810410 Active Cleared 5 Mar 1981

• Implantable Programmable Bipolar Cardiac (K800573)

  Class III

  FDA 510(k) K800573 Active Cleared 25 Mar 1980

• Laserpor Ap Atrial Endocard. Electr. Ld.

  Class III

  FDA 510(k) K820121 Active Cleared 12 Feb 1982

• Electrode, Model 030-324

  Class II

  FDA 510(k) K781822 Active Cleared 8 Feb 1979

See all devices from Telectronics, Inc. →

• What is the Stylet Introducer Funnel used for in a clinical setting?

  The Stylet Introducer Funnel is designed to assist in the insertion of pacing leads or catheter-based devices into the vascular system. Its tapered, funnel-shaped interface helps guide a stylet or guidewire, reducing potential trauma to the vessel and improving the precision of procedural insertion, particularly in cardiac electrophysiology labs or catheterization suites.

• Is the Stylet Introducer Funnel intended for single-use or reusable applications?

  The Stylet Introducer Funnel is explicitly intended for single-use in clinical settings. It is supplied sterile and packaged for aseptic use, ensuring safety and compliance with procedural standards.

• How is the Stylet Introducer Funnel regulated by the FDA?

  The device holds FDA 510(k) clearance under the classification for Permanent Pacemaker Electrode (DTB product code). It was granted clearance in 1986 via a traditional review process, with the decision confirming it as substantially equivalent to a predicate device. The submission was filed under the Cardiovascular advisory committee.

• What should be considered regarding disposal of the Stylet Introducer Funnel after use?

  Since the device is single-use and sterile, disposal should follow standard biohazard protocols for medical instruments. This ensures proper contamination control and compliance with clinical waste management guidelines.