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Endocardial Screw-In Lead with Platinum Porous Tip

by Diag Corp.

510(k) K852446

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 NumberK852446 Date17 Sep 1985ClearedStatusActive

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  • Withdrawn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, designed for endocardial fixation within the heart. It features a screw-in mechanism and a platinum porous tip to facilitate secure anchoring and electrical conduction, ensuring stable pacing functionality for patients requiring cardiac rhythm management.

The lead is intended for use in cardiac electrophysiology procedures, typically implanted during pacemaker or defibrillator installations. Supplied sterile and intended for single-use, it must be handled in a controlled environment to maintain sterility. Regulated under FDA 510(k) clearance (K852446) with a traditional review process, compliance with Class III device standards (regulation number 870.3680) is required. No MRI safety information is specified.

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