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Model 4951M Myocardial Unipolar Lead

by Metronic, Inc.

510(k) K031210

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 · Special NumberK031210 Date16 May 2003ClearedStatusActive

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  • Withdrawn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 Model 4951M Myocardial Unipolar Lead is a permanent pacemaker electrode designed for cardiac pacing applications. It delivers electrical stimulation to the myocardium to regulate heart rhythm in patients with bradycardia or other conduction disorders, ensuring consistent and reliable cardiac output.

This lead is intended for use in electrophysiology procedures within a sterile operating environment, typically implanted during cardiac surgery or interventional cardiology. Supplied as a single-use device, it must be handled with sterile techniques and stored in its original packaging until deployment. The device complies with FDA 510(k) clearance under classification III and is regulated under the permanent pacemaker electrode category (DTB), adhering to strict medical device standards for safety and performance.

Other devices from Metronic, Inc.