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Angemed 5000 Lead Adapter

by Angemed, Inc. 510(k)

Active United States

510(k) K924390

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK924390 Date25 Aug 1993ClearedStatusActive

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  • Withdrawn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
LDF
Device Class
Class II
Regulation
21 CFR Part 870.3680
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Angemed 5000 Lead Adapter is a temporary pacemaker electrode device. It is designed to facilitate the connection of leads within cardiovascular clinical applications.

This device is authorized under FDA 510(k) clearance K924390. It is classified as a Class II medical device under regulation number 870.3680.

Other devices from Angemed, Inc.