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Leads, Implantable Cardiac Pacemakers

FDA 510(k)

Class III (US FDA 510(k))

510(k) K782018

by Oscor Inc.

Identifiers

510(k) Number
K782018 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 implantable cardiac pacemaker lead, a component of a permanent pacemaker system designed to electrically stimulate the heart. It transmits pacing pulses from an implanted pulse generator to the heart tissue, facilitating proper cardiac rhythm in patients with bradycardia or conduction disorders. The leads are positioned within the heart chambers to ensure precise electrical conduction and synchronization of contractions.

Implantable cardiac pacemaker leads are surgically placed during a procedure and remain in the body long-term. They are supplied sterile and intended for single-use implantation, though some models may be reusable under specific reprocessing protocols as authorized by regulatory bodies. Compatibility with MRI environments varies by model, and sizes are standardized to fit specific anatomical and clinical requirements. Authorized under FDA 510(k) clearance (K782018), these leads adhere to regulatory standards for cardiovascular devices, including classification under device class 3 and regulation number 870.3680.

Frequently asked questions

Are these leads designed for reuse, or are they intended to be implanted as single-use devices?

These leads are primarily supplied sterile for single-use implantation. However, some models may be reusable under specific reprocessing protocols authorized by regulatory bodies, such as the FDA. Always verify the model’s documentation to confirm its reprocessing eligibility.

What anatomical or clinical requirements determine the size of these leads, and are there multiple sizes available?

The leads are standardized to fit specific anatomical and clinical requirements, ensuring compatibility with different patient needs. While exact sizes aren’t detailed here, the device is categorized under Permanent Pacemaker Electrode in regulatory records, implying multiple models may exist to accommodate varying heart chamber placements and patient anatomies.

How are these leads compatible with MRI environments, and should clinicians consider this when selecting a model?

MRI compatibility varies by model, as noted in the device description. Clinicians should consult the specific model’s documentation or technical specifications to determine whether a lead is MRI-safe or has restrictions. This is critical for patients who may require MRI scans in the future.

What regulatory pathway was followed for these leads, and how does that affect their use in clinical settings?

These leads were authorized through the FDA 510(k) clearance process (K782018) under the Traditional pathway, classified as Class 3 devices under regulation 870.3680. This pathway ensures they meet stringent safety and effectiveness standards for cardiovascular devices, giving clinicians confidence in their reliability for long-term 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

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Manufacturer

Manufacturer
Oscor Inc.
FDA Applicant
Oscor, Inc.

Sources (1)

  • FDA 510(k) K782018 24 fields · synced Sep 18, 2026