Skip to content

Multicor Gamma Models 336/337

by Cordis Corp.

510(k) K851417

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 NumberK851417 Date11 Jun 1985ClearedStatusActive

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  • Withdrawn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
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 Gamma Models 336/337 are implantable pacemaker pulse-generators, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. These devices are classified as Class III medical devices under FDA regulations, intended for patients requiring permanent pacing support due to bradycardia or other conduction disorders.

Supplied as sterile, single-use devices, the Multicor Gamma Models 336/337 are intended for surgical implantation by qualified healthcare professionals. They are regulated under FDA 510(k) clearance (K851417) and fall under product code DXY, adhering to the Traditional 510(k) review pathway. No MRI safety information or reusable specifications are provided in the regulatory data.

Other devices from Cordis US Corp.

See all devices from Cordis US Corp. →