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Ht, Model Ht Pb

by Sulzer Oscor, Inc.

510(k) K990142

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 NumberK990142 Date30 Jul 1999DecidedStatusActive

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  • Withdrawn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 HT Model HT-PB is a Permanent Pacemaker Electrode, designed for ventricular placement within the heart. It serves as an electrical conduit between an implantable pulse generator and cardiac muscle, enabling cardiac pacing through passive tined fixation.

This device is supplied sterile and intended for single-use implantation. Classified as a Class 3 medical device under Regulation 870.3680, it was granted FDA 510(k) clearance (K990142) in 1999 via the traditional pathway, with a Substantially Equivalent – Subject to Tracking designation. Compliance with product code DTB ensures adherence to cardiovascular device standards.

Other devices from Sulzer Oscor, Inc.

  • Pace 101H

    Class II

Questions

AI-generated answers, 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.

  • What is the primary purpose of the HT Model HT-PB and how does it function within the body?

    The HT Model HT-PB is a permanent pacemaker electrode designed specifically for ventricular placement in the heart. It acts as an electrical conduit between an implantable pulse generator and the cardiac muscle, enabling cardiac pacing through a passive tined fixation system. This ensures stable attachment to the heart tissue while delivering consistent pacing signals.

  • Is this device intended for single-use or can it be reused after implantation?

    The HT Model HT-PB is sterile upon supply and intended for single-use only. This design ensures patient safety by preventing contamination risks associated with reuse, which is critical for implanted medical devices.

  • What regulatory pathway was followed for FDA clearance, and what does the 'Subject to Tracking' designation mean?

    The HT Model HT-PB received FDA 510(k) clearance (K990142) via the traditional pathway in 1999. The ‘Subject to Tracking’ designation means the FDA monitors post-market performance more closely to ensure ongoing safety and effectiveness, particularly for Class 3 devices like this one.

  • Are there different sizes or models available for this pacemaker electrode?

    The provided data does not specify multiple sizes or models beyond the HT Model HT-PB, which is explicitly designed for ventricular placement. For exact sizing or alternative configurations, consult the manufacturer’s technical documentation or contact Sulzer Oscor directly.