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Modified Unipolar Implant. Pacing Leads W/Is-1

FDA 510(k)

Class III (US FDA 510(k))

510(k) K900984

by Medtronic Vascular

Identifiers

510(k) Number
K900984 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 Modified Unipolar Implant Pacemaker Leads with IS-1 are classified as Permanent Pacemaker Electrodes, designed for cardiac pacing applications. These leads deliver electrical stimulation to the heart muscle to regulate abnormal heart rhythms, ensuring proper cardiac function in patients requiring chronic pacing support.

These leads are intended for single-use implantation within the cardiovascular system and are supplied sterile. They are regulated under FDA 510(k) clearance (K900984) and fall under device class III (870.3680). Compatible with pacemaker systems, they are distributed in sterile packaging and must be handled according to aseptic procedures before use.

Frequently asked questions

Are these pacing leads designed for reuse or are they intended for single-use only?

These Modified Unipolar Implant Pacemaker Leads with IS-1 are explicitly designed for single-use implantation within the cardiovascular system. They are supplied sterile in packaging that must be maintained under aseptic conditions before use, reinforcing their intended one-time-use purpose.

What types of pacemaker systems are compatible with these leads, and how should they be handled before implantation?

These leads are compatible with pacemaker systems that utilize the IS-1 connector interface. Due to their sterile packaging, they must be handled using aseptic procedures to ensure sterility is preserved before implantation, as they are not intended for reuse.

How are these leads classified and regulated, and what does that mean for purchasing or clinical use?

These leads fall under FDA Class III (870.3680) and are regulated through a 510(k) clearance (K900984) with a *substantially equivalent* determination. This means they meet FDA standards for permanent pacemaker electrodes and are approved for cardiac pacing applications, ensuring compliance with strict safety and performance requirements for chronic use.

What connector type do these leads use, and does that affect compatibility with other devices?

These leads feature the IS-1 connector, which is a standardized interface for pacemaker leads. This connector type ensures compatibility with pacemaker systems designed to accept IS-1 leads, allowing for reliable electrical connection and pacing functionality.

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

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K900984 24 fields · synced Oct 6, 2026