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Model 486-03 Poly Flex Implantable Pacing Lead

by Intermedics, Inc. 510(k)

Active United States

510(k) K853411

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK853411 Date1 Oct 1985ClearedStatusActive

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  • Withdrawn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
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.

The Model 486-03 Poly Flex Implantable Pacing Lead is a Permanent Pacemaker Electrode (product code DTB), designed for implantation to facilitate cardiac pacing. It delivers electrical impulses to regulate heart rhythm in patients requiring chronic pacing support, ensuring proper conduction between the heart and an external pacemaker device.

This device is intended for single-use implantation and is classified as Class III under FDA regulations. Supplied sterile, it is regulated under FDA 510(k) clearance K853411, with a decision date of October 1, 1985. The lead is intended for use in cardiovascular procedures and adheres to regulatory requirements for permanent pacemaker electrodes, as outlined in regulation number 870.3680.

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