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Implantable Pacing Lead Models 487-06 to 430-01

by Intermedics, Inc.

510(k) K871580

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 NumberK871580 Date22 May 1987ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA Product Code
DTB
Device Class
Class III
Regulation
21 CFR Part 870.3680
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.

This device is a Permanent Pacemaker Electrode, classified as a Class III medical device under FDA regulations. It is designed for implantation within the cardiovascular system to deliver electrical stimulation to the heart, facilitating proper cardiac rhythm and function in patients requiring pacing support.

The leads are intended for single-use implantation in sterile conditions, typically within an operating room or cardiac catheterization laboratory. They are supplied sterile and must be handled using aseptic techniques. Each model (487-06 to 430-01) is regulated under FDA 510(k) clearance (K871580) and falls under the 870.3680 product code for pacemaker leads, adhering to cardiovascular device standards.

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