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Medtronic Model 4951P Permanent Pacemaker Electrode

by Medtronic Vascular

510(k) K881810

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK881810 Date13 Oct 1988ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Medtronic Model 4951P
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 Medtronic Model 4951P is a Permanent Pacemaker Electrode, designed for implantation in the cardiovascular system to facilitate cardiac pacing. It delivers electrical impulses to regulate heart rhythm in patients with bradycardia or other conduction disorders, ensuring consistent and reliable cardiac function.

This device is intended for single-use implantation and is supplied sterile. It is classified as a Class III medical device under FDA regulations (21 CFR 870.3680) and has received FDA 510K clearance through the Traditional pathway. The electrode is compatible with Medtronic pacemaker systems and requires proper surgical implantation by trained professionals in a sterile operating environment.

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