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Intermedics Thin Lith IV Series Unipolar

by Intermedics, Inc. 510(k)

Active United States

510(k) K801450

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK801450 Date14 Aug 1980ClearedStatusActive

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  • Withdrawn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 Intermedics Thin Lith IV Series Unipolar is an Implantable Pacemaker Pulse-Generator, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. This device is intended for use in patients requiring chronic cardiac pacing, providing reliable pacing functionality with a unipolar electrode configuration.

This device is supplied as a single-use, implantable medical product, intended for sterile surgical implantation. It is classified under FDA 510(k) clearance (K801450) and falls under Device Class III (DXY) for cardiovascular applications. Storage and handling must comply with sterile medical device protocols, and its regulatory status is confirmed through the FDA’s 510(k) submission process.

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