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Maestro Model 119 Single-Chamber Pacemaker

by Cardiac Control Systems, Inc.

510(k) K880422

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 NumberK880422 Date31 Mar 1988ClearedStatusActive

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  • Withdrawn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)

Full name
Maestro(R) Model 119, Single-Chamber Pacemaker
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 Maestro Model 119 is an implantable pulse-generator classified as a single-chamber pacemaker, designed to regulate heart rhythm by delivering electrical impulses to the right atrium or right ventricle. It is intended for patients with bradycardia or other conduction disorders requiring consistent cardiac pacing.

This device is implanted surgically and is intended for single-use within the body. It operates as a Class III medical device under FDA regulations, with a 510(k) clearance for substantial equivalence. The device is registered under the product code DXY and regulation number 870.3610, with no third-party involvement in its review.

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