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Microthin-DI Implantable Pacemaker Pulse-Generator

by Cardiac Pacemakers, Inc.

510(k) K800026

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 NumberK800026 Date31 Jan 1980ClearedStatusActive

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  • Withdrawn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
Microthin-Di
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 Microthin-DI Implantable Pacemaker Pulse-Generator is a Class III medical device classified under the FDA’s regulation number 870.3610. It functions as an implantable device designed to regulate heart rhythm by delivering electrical impulses to the heart when necessary, serving patients with bradycardia or other cardiac conduction disorders.

This device is supplied sterile and intended for single-use implantation. It is regulated under the FDA’s 510(k) clearance process, with a decision of Substantial Equivalence (SESE) granted in 1980. The Microthin-DI is manufactured by Cardiac Pacemakers, Inc., and adheres to cardiovascular medical specialty standards. No additional regulatory status beyond the stated FDA_510K clearance is implied.

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