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Pulse Generators, Models 5972/5973

FDA 510(k)

Class III (US FDA 510(k))

510(k) K780061

by Medtronic Vascular

Identifiers

510(k) Number
K780061 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 Pulse Generators, Models 5972/5973, are implantable pacemaker pulse-generators designed to regulate cardiac rhythm by delivering electrical impulses to the heart. Classified under product code DXY, these devices are intended for use in cardiovascular applications to manage bradycardia or other cardiac conduction disorders through controlled pacing stimulation.

These devices are supplied as reusable medical equipment and are regulated under FDA 510(k) clearance (K780061) as a Class III device, requiring premarket approval due to their high-risk, life-sustaining nature. Authorized for use in clinical settings, they are governed by FDA regulation number 870.3610 and were cleared in 1978 for cardiovascular applications. No additional sterility or MRI safety specifications are noted in the available data.

Frequently asked questions

Are these pulse generators designed for single-use or can they be reused in multiple patients?

These pulse generators, Models 5972/5973, are explicitly labeled as reusable medical equipment in the provided data. They are intended for implantation in individual patients and are not meant for single-use. Reuse is permitted within the context of their intended use in cardiovascular applications, though standard medical device reprocessing protocols must be followed to ensure safety and sterility between uses.

What types of cardiac conditions are these devices intended to address, and how do they work?

The Pulse Generators, Models 5972/5973, are designed to manage bradycardia or other cardiac conduction disorders by delivering controlled electrical impulses to regulate the heart’s rhythm. They function as implantable pacemakers, providing consistent pacing stimulation to ensure proper heart function in patients with slow or irregular heartbeats. The data does not specify exact conditions beyond these broad indications.

How are these devices regulated by the FDA, and what does the clearance status mean for clinical use?

These devices are classified as Class III under FDA regulations (870.3610) and were cleared via a 510(k) pathway (K780061) in 1978, with a decision of *Substantially Equivalent* (SESE). This classification reflects their high-risk, life-sustaining nature, requiring premarket approval to ensure safety and efficacy. The clearance confirms their compliance with FDA standards for use in cardiovascular applications, though clinical use must adhere to current medical guidelines and institutional protocols.

Are there any special storage requirements for these pulse generators before implantation?

The provided data does not specify any unique sterility or storage requirements beyond standard medical device handling for implantable electronics. Since they are reusable, they must be stored in a clean, dry environment to prevent contamination or damage before reprocessing and implantation. Always follow manufacturer guidelines and institutional protocols for device storage and preparation.

What is the regulatory history or timeline for these devices, and how does it impact their current use?

These pulse generators were originally cleared by the FDA in 1978 under the 510(k) process (K780061) and fall under product code DXY for cardiovascular applications. Their clearance was based on a *Substantially Equivalent* determination, meaning they were deemed comparable to legally marketed devices at the time. While the data does not detail ongoing regulatory updates, their long-standing clearance reflects their established role in managing bradycardia and conduction disorders, though clinicians should ensure compliance with updated clinical guidelines and institutional policies.

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: K780061 FDA 510 (k) - PULSE GENERATORS | Medtronic Vascular, Medtronic Vascular Pulse Generators, Models 5972/5973, PULSE GENERATORS, MODELS 5972/5973 - Innolitics, PULSE GENERATORS, MODELS 5972/5973 510(k) K780061 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K780061 24 fields · synced Oct 6, 2026