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Pacing Lead Model 6991A

FDA 510(k)

Class III (US FDA 510(k))

510(k) K772104

by Medtronic Vascular

Identifiers

510(k) Number
K772104 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 Pacing Lead Model 6991A is a permanent pacemaker electrode, designed to deliver electrical impulses to the heart for the management of cardiac rhythm disorders. It is intended for use in conjunction with a pacemaker system to stimulate the heart muscle and maintain proper heart rate and rhythm in patients with bradycardia or other conduction abnormalities.

This device is supplied sterile and intended for single-use implantation within the cardiovascular system. It is classified as a Class III medical device under FDA regulations (product code DTB) and was cleared through the 510(k) pathway in 1977. The lead is intended for use in MRI-unspecified environments unless otherwise specified by the manufacturer’s instructions. Storage and handling must comply with sterile medical device protocols.

Frequently asked questions

Is this pacing lead designed for reuse in patients, or is it meant to be implanted once and then discarded?

The Pacing Lead Model 6991A is intended for single-use implantation only. It is supplied sterile and should not be reused after implantation, as this could compromise patient safety and device efficacy. Sterility and single-use are critical for minimizing infection risks in cardiovascular procedures.

What types of cardiac rhythm disorders is this lead specifically intended to address?

This lead is designed to manage bradycardia and conduction abnormalities by delivering electrical impulses to the heart. It works in conjunction with a pacemaker system to stimulate the heart muscle and maintain proper heart rate and rhythm, ensuring consistent cardiac function in patients with these conditions.

How should this device be stored to maintain its sterility and integrity before use?

The lead must be stored and handled according to sterile medical device protocols to preserve its integrity. Since it is supplied sterile, it should remain in its original packaging until immediately before implantation, avoiding exposure to contaminants or environmental conditions that could compromise sterility.

Can this lead be used in patients who require MRI scans, or are there specific restrictions?

The lead is not explicitly labeled as MRI-compatible, meaning its use in MRI environments is unspecified unless the manufacturer’s instructions specify otherwise. Clinicians should consult Medtronic’s guidelines or the device labeling to determine MRI safety before proceeding with imaging studies.

What regulatory pathway was followed for this device’s clearance, and what does that mean for its safety and efficacy?

The Pacing Lead Model 6991A was cleared through the FDA’s 510(k) pathway in 1977 under the classification of a Class III medical device (product code DTB). This pathway demonstrates that the device is substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and performance standards for permanent pacemaker electrodes. The clearance was reviewed by the Cardiovascular (CV) Advisory Committee.

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: Pacing Lead Model 6991a - Medtronic Vascular | FDA Evidence Review, PACING LEAD MODEL 6991A (K772104) - FDA 510 (k), PACING LEAD MODEL 6991A (K772104) — FDA 510 (k) | Innolitics, Medtronic Temporary Sensing and Pacing Leads

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K772104 24 fields · synced Oct 6, 2026