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Multicor (Gamma) Model 336 & Model 337

by Cordis Corp.

510(k) K801106

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 NumberK801106 Date8 Jul 1980ClearedStatusActive

Official records

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  • Withdrawn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) Model 336 & Model 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, requiring pre-market approval due to their role in life-sustaining or supporting functions.

These pulse generators are intended for surgical implantation and are supplied sterile for single-use. They are regulated under FDA 510(k) clearance (K801106) and fall under the medical specialty of cardiovascular devices. Storage and handling must comply with sterile medical device protocols, and their use is governed by the FDA’s regulation number 870.3610 for implantable pacemaker pulse generators.

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