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Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped Tined Pacing Leads

by Ela Medical, Inc. 2 variants

510(k) K000029

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 NumberK000029 Date4 Apr 2000ClearedStatusActive

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  • Withdrawn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 Stela UT46 and BT45/46 Straight Tined Pacing Leads, along with the Stela UJ45 and BJ44/45 J-Shaped Tined Pacing Leads, are classified as Permanent Pacemaker Electrodes. These devices are designed to deliver electrical impulses to the heart, facilitating cardiac pacing by stimulating the right atrium or ventricle during implantation with an implantable cardiac pacemaker.

These pacing leads are intended for single-use implantation in either the atrium (J-shaped leads) or ventricle (straight tined leads). They are supplied sterile and are regulated under FDA 510(k) clearance (K000029) as a Class III device under regulation number 870.3680. The leads are intended for use in cardiovascular procedures and are distributed by Ela Medical, Inc.

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