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Bipolar Endocardial Pacing Lead M. 6902

FDA 510(k)

Class III (US FDA 510(k))

510(k) K780622

by Medtronic Vascular

Identifiers

510(k) Number
K780622 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 Bipolar Endocardial Pacing Lead M. 6902 is a permanent pacemaker electrode designed for endocardial pacing. It delivers electrical stimulation to the heart’s inner lining, facilitating ventricular pacing in patients requiring cardiac rhythm management. This bipolar configuration helps reduce pacing thresholds and improve lead stability, minimizing complications associated with traditional pacing leads. The device is classified as a Class III medical device under FDA regulations.

This bipolar endocardial pacing lead is supplied sterile and intended for single-use implantation within the heart’s endocardial tissue. It is regulated under FDA 510(k) clearance (K780622) and falls under product code DTB for permanent pacemaker electrodes. The device is intended for use in cardiac electrophysiology procedures and must be handled under sterile conditions. No additional regulatory approvals beyond the stated 510(k) clearance are referenced in the available data.

Frequently asked questions

What is the primary purpose of the Bipolar Endocardial Pacing Lead, M. 6902, and how does its bipolar design benefit patients?

The Bipolar Endocardial Pacing Lead, M. 6902, is designed for endocardial pacing, delivering electrical stimulation directly to the heart’s inner lining to facilitate ventricular pacing in patients requiring cardiac rhythm management. The bipolar configuration reduces pacing thresholds and enhances lead stability, which minimizes complications like dislodgment or high impedance often seen with traditional pacing leads.

Is this device intended for reuse, or is it meant to be implanted as a single-use item? How should it be handled?

The Bipolar Endocardial Pacing Lead, M. 6902, is sterile and intended for single-use implantation only. Due to its sterile packaging and endocardial application, it must be handled under strict aseptic conditions to prevent infection or contamination during the procedure.

What regulatory pathway does this device follow, and what does that mean for its use in clinical settings?

This device follows the FDA 510(k) clearance pathway (K780622) and is classified as a Class III medical device under FDA regulations. The clearance indicates it is deemed substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and effectiveness standards for permanent pacemaker electrodes in cardiac electrophysiology procedures.

Are there multiple sizes or models of this lead, and if so, how are they differentiated?

The provided data does not specify distinct sizes or models beyond the M. 6902 designation, which is the primary identifier for this bipolar endocardial pacing lead. However, the OpenFDA registration numbers suggest multiple lot or batch variations may exist, but these are administrative identifiers, not clinical differentiators. For exact sizing or model variations, consult the manufacturer’s technical documentation.

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: Bipolar Endocardial Pacing Lead M 6902 - Medtronic Vascular | FDA ..., BIPOLAR ENDOCARDIAL PACING LEAD, M. 6902 (K780622) — FDA 510 (k ..., BIPOLAR ENDOCARDIAL PACING LEAD, M. 6902 (K780622) - FDA 510 (k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K780622 24 fields · synced Oct 6, 2026