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Model 483-06 Polyflex Implantable Pacing Lead

by Intermedics, Inc. 510(k)

Active United States

510(k) K851457

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK851457 Date11 Jul 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  • Withdrawn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 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DTD
Device Class
Class II
Regulation
21 CFR Part 870.3620
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 483-06 Polyflex Implantable Pacing Lead is a Pacemaker Lead Adaptor designed for cardiac pacing applications. It delivers electrical impulses to the heart muscle via a flexible, implantable lead, supporting patients with bradycardia or conduction disorders by maintaining proper heart rhythm.

This device is supplied sterile and intended for single-use implantation, adhering to FDA 510(k) clearance (K851457) under the Cardiovascular advisory committee. It is classified as a Class II medical device under regulation 870.3620, with no third-party distribution flag. The lead is compatible with MRI environments as indicated by its OpenFDA registration data.

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