← Back to catalogue

Model MF..D & MX..D Pacemaker Leads

FDA 510(k)

Class III (US FDA 510(k))

510(k) K823898

by Oscor Inc.

Identifiers

510(k) Number
K823898 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 MF..D & MX..D Pacemaker Leads are classified as Permanent Pacemaker Electrodes, designed for implantation in the cardiovascular system to stimulate the heart muscle. These leads deliver electrical impulses to regulate abnormal heart rhythms, ensuring proper cardiac function in patients with bradycardia or other conduction disorders.

These leads are supplied sterile and intended for single-use implantation, adhering to FDA 510(k) clearance under the Traditional pathway. They are categorized under device classification III and regulated under the regulation number 870.3680. The leads are distributed in sterile packaging and must be handled according to aseptic techniques prior to use.

Frequently asked questions

Are these pacemaker leads reusable or intended for single-use only, and how should they be handled before implantation?

These leads are designed for single-use only and come sterile in sealed packaging. They must be handled using aseptic techniques to maintain sterility before implantation, as per manufacturer guidelines.

What types of heart conditions are these leads intended to address, and how do they work?

These leads are permanent pacemaker electrodes used to treat bradycardia and conduction disorders by delivering electrical impulses to stimulate the heart muscle, ensuring proper cardiac rhythm.

What regulatory pathway was followed for FDA clearance, and what classification does this device fall under?

The leads were cleared via the FDA 510(k) Traditional pathway and are classified as Class III, regulated under 21 CFR 870.3680, with a decision of *Substantially Equivalent* (SESE).

How are these leads packaged and distributed, and what storage considerations should be noted?

The leads are supplied in sterile packaging and must be stored according to manufacturer instructions to preserve sterility. They are intended for aseptic handling prior to implantation.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Oscor Inc.
FDA Applicant
Oscor, Inc.

Sources (1)

  • FDA 510(k) K823898 24 fields · synced Sep 18, 2026