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Quantum(R) Models 253-19V & 254-20V Pulse Genera.

by Intermedics, Inc. 510(k)

Active United States

510(k) K874394

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK874394 Date23 Nov 1987ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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 Quantum Models 253-19V & 254-20V Pulse Generator is an Implantable Pacemaker Pulse-Generator, a Class III medical device designed to provide electrical stimulation for cardiac pacing. These devices are intended for use in patients requiring artificial cardiac pacing to regulate heart rhythm by delivering timed electrical impulses to the heart muscle.

These pulse generators are supplied as reusable, implantable devices and are regulated under FDA 510(k) clearance (K874394) with a decision classification of Substantially Equivalent. They are intended for use in cardiovascular settings and adhere to regulatory standards outlined in 21 CFR 870.3610. Models 253-19V and 254-20V are identified by their specific reference codes and are not single-use, requiring proper surgical implantation and maintenance in accordance with medical guidelines.

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