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Model KY Pacemaker Lead

FDA 510(k)

Class III (US FDA 510(k))

510(k) K823891

by Oscor Inc.

Identifiers

510(k) Number
K823891 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 KY Pacemaker Lead is a permanent pacemaker electrode, designed as a cardiac lead for use with pacemakers. It is intended for electrical stimulation of the heart to regulate cardiac rhythm in patients with bradycardia or conduction disorders.

This device is supplied in various lengths and configurations to accommodate different patient anatomies and surgical techniques. It is classified as a Class III medical device and was cleared through the FDA 510(k) pathway in 1983 under the product code DTB. The lead is intended for single-use implantation and requires sterile handling, with regulatory compliance ensured by FDA authorization.

Frequently asked questions

What types of patients is the Model KY Pacemaker Lead designed to support, and how does its design accommodate different patient needs?

The Model KY Pacemaker Lead is designed for patients with bradycardia or conduction disorders requiring electrical stimulation of the heart to regulate rhythm. It comes in various lengths and configurations to match different patient anatomies and surgical techniques, ensuring flexibility for implantation.

Is the Model KY Pacemaker Lead intended for reuse, or is it meant for single-use implantation only?

The Model KY Pacemaker Lead is explicitly intended for single-use implantation and requires sterile handling. Reuse is not recommended or supported by the manufacturer’s design or regulatory clearance.

What regulatory pathway was used for FDA clearance of this device, and what does that mean for its safety and compliance?

The Model KY Pacemaker Lead was cleared through the FDA 510(k) pathway under product code DTB in 1983, with a substantially equivalent determination. This means it was reviewed by the FDA’s Cardiovascular (CV) advisory committee to ensure it meets safety and performance standards comparable to legally marketed predecessors, ensuring compliance with U.S. regulatory requirements.

How should the Model KY Pacemaker Lead be stored to maintain sterility and integrity before use?

Since the lead is intended for sterile single-use implantation, it must be stored in its original packaging until ready for use. The manufacturer’s instructions (not provided here) should specify environmental conditions, but generally, protection from moisture, extreme temperatures, and physical damage is critical to preserve sterility and functionality.

Are there multiple sizes or models available for the Model KY Pacemaker Lead, and how does this affect its compatibility with pacemaker systems?

The Model KY Pacemaker Lead is supplied in various lengths and configurations to accommodate different patient anatomies and surgical approaches. While the exact sizes aren’t detailed here, the variability ensures compatibility with a range of pacemaker systems and implantation techniques, though final compatibility should be verified with the specific pacemaker manufacturer’s guidelines.

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 KY Pacemaker Lead - Oscor | FDA Evidence Review, MODEL KY PACEMAKER LEAD - VARIOUS (K823891) — FDA 510 (k) | Innolitics, Model KY Pacemaker Lead - Oscor Medical | FDA Reference, Model Ky Pacemaker Lead - Various 510 (k) FDA Premarket Notification ...

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) K823891 24 fields · synced Sep 18, 2026