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Model Mz Pacemaker Lead-Various

FDA 510(k)

Class III (US FDA 510(k))

510(k) K823893

by Oscor Inc.

Identifiers

510(k) Number
K823893 FDA 510(k)
FDA Product Code
DTB FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 870.3680 FDA 510(k)
Regulation Number
870.3680 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Model MZ Pacemaker Lead is a Permanent Pacemaker Electrode, designed to establish an electrical connection between an implanted pacemaker and the heart muscle. It facilitates the delivery of pacing impulses to regulate abnormal heart rhythms in patients requiring cardiac pacing support.

This device is intended for single-use implantation by cardiologists in a sterile operating environment. It falls under FDA regulation 870.3680 and was granted FDA 510(k) clearance (K823893) under the Traditional 510(k) Review process, classified as a Class III medical device. Multiple model variants are listed under the product code DTB, with no indication of MRI compatibility or reusable design.

Frequently asked questions

What types of heart conditions is the Model MZ Pacemaker Lead designed to address, and how does it work?

The Model MZ Pacemaker Lead is designed to establish an electrical connection between an implanted pacemaker and the heart muscle, specifically to deliver pacing impulses. It is intended for patients requiring cardiac pacing support to regulate abnormal heart rhythms, such as bradycardia (slow heart rate) or certain arrhythmias where the heart’s natural electrical system is insufficient.

Is the Model MZ Pacemaker Lead reusable, or is it meant for single-use implantation only?

The Model MZ Pacemaker Lead is explicitly intended for single-use implantation by cardiologists in a sterile operating environment. It is not designed for reuse, as this would compromise sterility and patient safety.

What sizes or model variants are available for the Model MZ Pacemaker Lead, and how are they differentiated?

Multiple model variants of the Model MZ Pacemaker Lead are available, each listed under the product code DTB. While exact specifications (e.g., lead length, electrode type, or fixation mechanism) are not detailed here, the variants are likely differentiated by technical features such as electrode positioning, tine design, or intended implantation site (e.g., right atrium, right ventricle, or biventricular). For precise sizing or model selection, refer to the manufacturer’s catalog or clinical documentation.

How should the Model MZ Pacemaker Lead be stored before implantation, and what precautions should be taken?

Since the Model MZ Pacemaker Lead is intended for single-use in a sterile operating environment, it should be stored in its original, sealed packaging until immediately before use. Storage conditions typically include protection from moisture, extreme temperatures, and physical damage. Always follow the manufacturer’s instructions for shelf life and handling to ensure sterility and functionality.

What regulatory pathway was followed for FDA clearance of the Model MZ Pacemaker Lead, and what does this mean for clinicians?

The Model MZ Pacemaker Lead received FDA 510(k) clearance (K823893) under the Traditional 510(k) Review process, classified as a Class III medical device. This means it was determined to be *substantially equivalent* to a legally marketed predicate device and meets FDA safety and effectiveness requirements for permanent pacemaker electrodes. Clinicians can rely on this clearance as evidence of regulatory scrutiny, though they should always consult the latest labeling or manufacturer guidelines for specific implantation protocols.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Model MZ Pacemaker Lead-Various - Oscor | FDA Reference, MODEL MZ PACEMAKER LEAD-VARIOUS (K823893) — FDA 510 (k) | Innolitics, MODEL MZ PACEMAKER LEAD-VARIOUS 510 (k) K823893 - FDA.report, PDF Product Portfolio - Implantable cardiac pacing leads, introducer ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Oscor Inc.
FDA Applicant
Oscor, Inc.

Sources (1)

  • FDA 510(k) K823893 24 fields · synced Sep 18, 2026