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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) K993448

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)ST Traditional NumberK993448 Date10 Apr 2000DecidedStatusActive

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  • Withdrawn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
ST

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 muscle, facilitating proper heart rhythm regulation in patients with bradycardia or other conduction disorders. The leads feature tined fixation mechanisms to secure placement within the cardiac chambers, ensuring stable and reliable pacing functionality over time.

These pacing leads are intended for use in cardiac electrophysiology procedures, typically implanted during pacemaker or implantable cardioverter-defibrillator (ICD) surgeries. They are supplied sterile and are classified as single-use devices, though they may be reused per manufacturer guidelines. The leads are regulated under FDA 510(k) clearance (K993448) and fall under the Cardiovascular advisory committee classification. They are designed for MRI safety compliance as outlined in the relevant regulatory standards, with specific models listed under the product code DTB and regulation number 870.3680.

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