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Endocardial Pacing Leads-Anchoring Sleeve Modified

FDA 510(k)

Class III (US FDA 510(k))

510(k) K884005

by Medtronic Vascular

Identifiers

510(k) Number
K884005 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)

This device is an Endocardial Pacing Lead, classified as a Permanent Pacemaker Electrode, designed to facilitate electrical stimulation of the heart. The anchoring sleeve modification enhances fixation within the endocardial tissue, ensuring stable positioning for reliable pacing functionality in cardiac rhythm management applications.

The Endocardial Pacing Leads-Anchoring Sleeve Modified is intended for single-use implantation in cardiac electrophysiology procedures. Supplied sterile, it is regulated under FDA 510K clearance (K884005) and falls under Device Type DTB, adhering to 870.3680 regulatory standards. Compatible with MRI environments as indicated by its classification, it is distributed in sterile packaging for direct surgical use.

Frequently asked questions

What is the primary purpose of the anchoring sleeve modification on this endocardial pacing lead?

The anchoring sleeve modification is designed to improve fixation within the endocardial tissue, ensuring the lead remains securely positioned during implantation. This stability is critical for reliable electrical stimulation of the heart in cardiac rhythm management procedures, reducing the risk of displacement or loosening over time.

Is this device intended for reuse, or is it meant to be used only once during a procedure?

This device is explicitly intended for single-use implantation in cardiac electrophysiology procedures. It is supplied sterile and packaged for direct surgical use, meaning it should not be reused after a single procedure.

What types of MRI environments is this pacing lead compatible with, and why does that matter?

This endocardial pacing lead is classified as MRI-compatible, meaning it can be used in patients who require magnetic resonance imaging (MRI) scans. This is important for patients who may need both cardiac pacing and MRI evaluations, as traditional leads could pose risks in MRI environments due to electromagnetic interference or heating.

How is this device regulated, and what does the FDA 510K clearance indicate about its safety and effectiveness?

This device received FDA 510K clearance (K884005) under the Traditional 510(k) pathway, meaning it was determined to be substantially equivalent to a legally marketed predicate device. This clearance indicates that the FDA reviewed its design, manufacturing processes, and clinical rationale to confirm it meets regulatory standards for safety and performance in its intended use for permanent pacing applications.

What storage or handling precautions should be taken with this sterile packaging?

Since the device is supplied sterile in packaging for direct surgical use, it should be stored in a clean, dry environment protected from contamination until ready for implantation. The packaging integrity must remain unbroken until use to maintain sterility, and standard aseptic techniques should be followed during handling to prevent compromise.

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) K884005 24 fields · synced Oct 6, 2026