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Multicor II 402B & 402C Multiprogram Cardiac Pacemaker

by Cordis Corp.

510(k) K854214

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 NumberK854214 Date3 Dec 1985ClearedStatusActive

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  • Withdrawn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
Multicor II 402B & 402C Multiprogram. Cardiac Pace
510(k) Number
FDA product code
DXY
Device class
Class III
Regulation
21 CFR Part 870.3610
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 Multicor II 402B & 402C Multiprogram Cardiac Pacemaker is an implantable pacemaker pulse-generator designed to regulate cardiac rhythm in patients with bradycardia or conduction disorders. It delivers timed electrical impulses to the heart to maintain a consistent and effective heartbeat, ensuring proper cardiac function in patients requiring chronic pacing support.

This device is intended for implantable use and is classified as a Class III medical device under FDA regulations, requiring premarket approval. Supplied sterile and intended for single-use implantation, it is regulated under product code DXY and authorized via FDA 510(k) clearance (K854214). The device is manufactured by Cordis Corp. and is intended for use in cardiovascular applications, adhering to strict regulatory standards for life-sustaining medical devices.

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