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Pacing Leads (3262VU +5 more) - 3380

by Pace Medical

510(k) K874743

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 NumberK874743 Date19 Jan 1988ClearedStatusActive

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  • Withdrawn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
Models / Variants
3380
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.

This device is a Permanent Pacemaker Electrode, designed to interface with cardiac pacemakers for the electrical stimulation of the heart. It facilitates rhythm regulation in patients with bradycardia or other conduction disorders by delivering precise pacing impulses to the right atrium, right ventricle, or both chambers, as indicated by its dual-chamber or single-chamber configurations.

The Pacing Leads are supplied sterile and intended for single-use implantation. They are classified as Class III medical devices under FDA regulations (870.3680) and were granted Substantially Equivalent clearance via a Traditional 510(k) pathway. Available in models 3262VU/VB, 3362VU/VB, 3380, and 3390, these leads are intended for use in cardiovascular procedures and must be handled and stored according to manufacturer guidelines to maintain sterility and functionality.

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