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Modified Ancor Hi-Flex Unipolar Active Fix Lead

by Tpl-Cordis, Inc.

510(k) K885240

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 NumberK885240 Date10 Feb 1989ClearedStatusActive

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  • Withdrawn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 under FDA product code DTB, designed for unipolar cardiac pacing. It incorporates an active fixation mechanism to ensure secure attachment to the heart tissue, facilitating reliable electrical conduction for pacing applications in cardiovascular patients.

The Modified Ancor Hi-Flex Unipolar Active Fix Lead is intended for single-use implantation in sterile conditions, typically within cardiac electrophysiology settings. It is regulated under FDA 510(k) clearance (K885240) and falls under Class III medical device classification, adhering to regulatory standards for permanent pacemaker leads. No MRI safety or reusable specifications are noted in the available data.

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