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Vs-1 Lead Ext. 033-302, 4.75mm 033-260, 033-458

by Telectronics Pacing Systems, Inc.

510(k) K901402

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK901402 Date12 Jun 1990ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The VS-1 Lead Extension is a Permanent Pacemaker Electrode, designed for use in cardiac pacing systems. It serves as an extension lead to connect pacing electrodes to the pulse generator, facilitating electrical signal transmission for ventricular pacing in patients with bradycardia or conduction disorders.

These leads are supplied as single-use, sterile devices and are intended for use in electrophysiology laboratories or cardiac catheterization suites. They are available in three sizes: 033-302, 033-260, and 033-458, with a 4.75mm connector. The device is MRI-unsafe and must be handled according to manufacturer guidelines. FDA clearance (K901402) under 510(k) Traditional Review was granted in 1990 for cardiovascular applications.

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