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Microlith A Model 703 Implantable Pacemaker Pulse-Generator

by Cardiac Pacemakers, Inc.

510(k) K782022

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 NumberK782022 Date22 Dec 1978ClearedStatusActive

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  • Withdrawn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
Microlith a Model 703
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 Microlith A Model 703 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 spontaneous contractions are insufficient. It is intended for patients with bradycardia or other conduction disorders requiring chronic cardiac pacing support.

This device is supplied sterile and intended for single-use implantation by a qualified physician in a clinical setting. It is regulated under FDA 510(k) clearance (K782022) and falls under the Implantable Pacemaker Pulse-Generator nomenclature (DXY), adhering to regulatory standards for Class III devices. Storage and handling must comply with manufacturer guidelines to maintain sterility and functionality.

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Questions

AI-generated answers, 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.

  • What is the primary clinical purpose of the Microlith A Model 703, and who should consider using it?

    The Microlith A Model 703 is designed to regulate heart rhythm by delivering electrical impulses to the heart muscle, specifically for patients with bradycardia or conduction disorders requiring chronic cardiac pacing support. It is intended for single-use implantation by qualified physicians in clinical settings where patients need reliable, long-term pacing assistance.

  • Is the Microlith A Model 703 meant for reuse, or is it intended for single-use only?

    The Microlith A Model 703 is explicitly supplied sterile and intended for single-use implantation only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and device functionality.

  • How should the Microlith A Model 703 be stored to ensure sterility and proper functionality?

    The device must be stored and handled according to the manufacturer’s guidelines to maintain sterility and functionality. Since it is supplied sterile and intended for single-use, proper packaging integrity and adherence to storage conditions (e.g., temperature, humidity) are critical before implantation.

  • What regulatory pathway does the Microlith A Model 703 follow, and how does that affect its use?

    The Microlith A Model 703 is regulated under the FDA 510(k) clearance process (K782022) and classified as a Class III medical device. This designation ensures it meets stringent safety and effectiveness standards for implantable pacemaker pulse-generators, requiring compliance with regulatory requirements before clinical use.