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Telectronics Srew-in/Slim Line Pacing Leads

by Daig Corp. 510(k)

Active United States

510(k) K864098

Overview

The Telectronics Screw-In/Slim Line Pacing Leads are Permanent Pacemaker Electrodes, designed for implantation in the heart to deliver electrical stimulation for cardiac pacing. These leads feature a screw-in mechanism for secure fixation within the cardiac chamber, ensuring stable electrode contact for reliable pacing therapy.

These leads are intended for single-use and are classified under FDA product code DTB, with a 510(k) clearance (K864098) granted in 1986. They are supplied sterile and intended for use in cardiac electrophysiology procedures, adhering to Class III regulatory standards. No additional storage or MRI safety information is specified in the available data.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK864098 Date5 Dec 1986ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DTB
Device Class
Class III
Regulation
21 CFR Part 870.3680
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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