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Multicor ST, Model 350A

by Cordis Corp.

510(k) K851968

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 NumberK851968 Date14 Jan 1986ClearedStatusActive

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  • Withdrawn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
Cordis Multicor St, Model 350A
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 ST, Model 350A is an Implantable Pacemaker Pulse-Generator, a Class III medical device designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when natural electrical activity is insufficient. This device is intended for patients requiring chronic cardiac pacing to manage bradycardia or other conduction disorders.

This device is supplied as a reusable, implantable component and is regulated under FDA 510(k) clearance (K851968) with a Substantially Equivalent determination. It falls under the Cardiovascular specialty and is classified under regulation 870.3610, requiring strict adherence to high-risk, life-sustaining device standards. No additional sterility or MRI safety specifications are noted in the available data.

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