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Model Sz Pacemaker Lead-Various

by Dr. Ing. P. Osypka, GmbH 510(k)

Active United States

510(k) K823892

Overview

The Model SZ Pacemaker Lead is a Permanent Pacemaker Electrode, designed to deliver electrical impulses to the heart for pacing purposes. It is intended for use in patients with bradycardia or other cardiac conduction disorders requiring chronic cardiac stimulation.

This device is supplied as a reusable component for integration with pacemaker systems and is classified under FDA 510(k) clearance (K823892) as a Traditional submission. It falls under Device Type DTB and is regulated under 21 CFR 870.3680, with no third-party involvement. The lead is intended for sterile use in clinical settings and must be handled according to medical device sterilization and handling protocols.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK823892 Date30 Apr 1983ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

Other devices from Dr. Ing. P. Osypka, GmbH

Questions

  • What is the primary clinical purpose of the Model SZ Pacemaker Lead-Various and who would benefit from it?

    The Model SZ Pacemaker Lead-Various is designed to deliver electrical impulses to the heart for pacing, specifically addressing patients with bradycardia or other cardiac conduction disorders requiring chronic cardiac stimulation. It is intended for use in clinical settings where patients need consistent, long-term heart rhythm regulation, such as those with slow heart rates or abnormal electrical signaling in the heart.

  • Is the Model SZ Pacemaker Lead-Various intended for single-use or can it be reused after implantation?

    The Model SZ Pacemaker Lead-Various is supplied as a reusable component for integration with pacemaker systems. While it is intended for sterile use in clinical settings, it is not a single-use device. It must be handled according to medical device sterilization and handling protocols to ensure safety and efficacy during reuse.

  • How is the Model SZ Pacemaker Lead-Various regulated, and what does that mean for its use in clinical practice?

    The Model SZ Pacemaker Lead-Various holds an FDA 510(k) clearance (K823892) under a Traditional submission, classified as a Permanent Pacemaker Electrode. This means it has been determined to be substantially equivalent to a legally marketed device and is regulated under 21 CFR 870.3680. Clinically, this indicates it meets established safety and performance standards for use in pacing applications, though it must still be used as directed by medical professionals.

  • What types of pacemaker systems can the Model SZ Pacemaker Lead-Various be integrated with, and how is it supplied?

    The Model SZ Pacemaker Lead-Various is designed as a reusable component intended for integration with various pacemaker systems. It is not a standalone device but rather a critical electrode component that connects to pacemakers to deliver pacing impulses. The lead is supplied sterile for clinical use, ensuring it meets medical-grade standards before implantation.

  • Are there different sizes or models of the Model SZ Pacemaker Lead-Various, and how would a clinician determine the correct one for a patient?

    The Model SZ Pacemaker Lead-Various is listed under multiple FEI numbers (e.g., 3002618605, 1028232), which may correspond to variations in lead design, length, or electrode configuration. While the exact specifications for each variation are not detailed here, clinicians would typically select the appropriate size or model based on the patient’s anatomy, pacing requirements, and compatibility with the chosen pacemaker system. Consulting the manufacturer’s technical documentation or a cardiologist specializing in pacing is recommended for precise selection.