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Ela Medical Pacing Leads Pmc 860 Pmcf 860 PBCF860

by Ela Medical, Inc.

510(k) K851731

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 NumberK851731 Date29 Aug 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  • Withdrawn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.

The Ela Medical Pacing Leads PMC 860, PMCF 860, and PBCF 860 are classified as Permanent Pacemaker Electrodes, designed for use in cardiac pacing systems. These leads are intended to deliver electrical impulses to stimulate the heart, ensuring proper rhythm and function in patients with bradycardia or other pacing indications.

These leads are supplied sterile and intended for single-use, though they may be reusable under specific clinical conditions. They are regulated under FDA 510(k) clearance (K851731) and fall under the DTB product code, adhering to cardiovascular medical device standards. Storage and handling must comply with manufacturer guidelines to maintain sterility and functionality.

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