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Medtronic Enertrax Model 7100

FDA 510(k)

Class III (US FDA 510(k))

510(k) K822147

by Medtronic Vascular

Identifiers

510(k) Number
K822147 FDA 510(k)
FDA Product Code
DXY FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 870.3610 FDA 510(k)
Regulation Number
870.3610 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Medtronic Enertrax Model 7100 is an implantable pacemaker pulse-generator, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. This device is classified as a Class 3 Cardiovascular implant and is intended for patients requiring permanent pacing support to manage bradycardia or other conduction disorders.

This device is supplied sterile and intended for single-use implantation by qualified healthcare professionals in a clinical setting. It is regulated under FDA 510(k) clearance (K822147) and falls under product code DXY, adhering to traditional review pathways. Storage and handling must comply with manufacturer guidelines to maintain sterility and functionality prior to use.

Frequently asked questions

What clinical conditions is the Medtronic Enertrax Model 7100 designed to address in patients?

The Medtronic Enertrax Model 7100 is intended for patients requiring permanent pacing support to manage bradycardia or other conduction disorders. It regulates cardiac rhythm by delivering electrical impulses to the heart, ensuring consistent and appropriate heartbeats for those with slow or irregular heart rates.

Is the Medtronic Enertrax Model 7100 meant for reuse, or is it single-use only?

The device is explicitly sterile and intended for single-use implantation by qualified healthcare professionals. Reuse is not recommended, as it could compromise sterility and functionality, potentially leading to infection or device failure.

How should the Medtronic Enertrax Model 7100 be stored to maintain its integrity before use?

Storage and handling must follow manufacturer guidelines to preserve sterility and functionality. Since it is sterile upon supply, it should be kept in its original packaging until implantation, protected from contamination, moisture, and physical damage.

What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

The Medtronic Enertrax Model 7100 received FDA 510(k) clearance (K822147) under the traditional review pathway, with a substantially equivalent determination. This means it was compared to a legally marketed predicate device, confirming it meets safety and effectiveness standards for implantable pacemaker pulse-generators as classified under Class 3 in cardiovascular applications.

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: K822147 FDA 510 (k) - MEDTRONIC ENERTRAX MODEL 7100, MEDTRONIC ENERTRAX MODEL 7100 (K822147) — FDA 510(k) | Innolitics, MEDTRONIC ENERTRAX MODEL 7100 (K812096) - FDA 510(k), MEDTRONIC ENERTRAX MODEL 7100 (K812096) - FDA 510(k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K822147 24 fields · synced Oct 6, 2026