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Multi-Programmable Pacemaker & Progrmr.

FDA 510(k)

Class III (US FDA 510(k))

510(k) K801584

by Medtronic Vascular

Identifiers

510(k) Number
K801584 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)

This device is an Implantable Pacemaker Pulse-Generator, a Class III medical device designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when needed. It is programmable to adjust pacing parameters, allowing customisation for individual patient requirements, and is intended for use in patients with bradycardia or other cardiac conduction disorders requiring artificial pacing support.

The Multi-Programmable Pacemaker & Programmer is supplied as a reusable, implantable device and is paired with a dedicated external programmer for configuration. It is classified under product code DXY and has received FDA 510(k) clearance (K801584) under the Traditional pathway, with a decision date of February 12, 1981. No specific sterility or MRI safety information is provided in the regulatory data, and no details on packaging or storage conditions are included.

Frequently asked questions

What is the primary purpose of the Multi-Programmable Pacemaker & Programmer, and who is it designed for?

The Multi-Programmable Pacemaker & Programmer is designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when needed. It is intended for patients with bradycardia or other cardiac conduction disorders requiring artificial pacing support. The device’s programmability allows customization of pacing parameters to meet individual patient needs.

How is the Multi-Programmable Pacemaker & Programmer supplied and used in a clinical setting?

The device is supplied as a reusable, implantable pacemaker pulse-generator. It is paired with a dedicated external programmer for configuration and adjustment of pacing parameters. The pacemaker itself is implanted in the patient, while the programmer is used externally to fine-tune settings.

Is the Multi-Programmable Pacemaker & Programmer intended for single-use or can it be reused?

The device is explicitly described as reusable, meaning it is designed for repeated use in patients after proper maintenance and sterilization procedures. However, the regulatory data does not specify sterilization methods or storage conditions, so clinical protocols should be followed to ensure safe reuse.

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

The Multi-Programmable Pacemaker & Programmer received FDA clearance under the Traditional 510(k) pathway, with a decision date of February 12, 1981. This means the device was determined to be substantially equivalent to a legally marketed predicate device, allowing it to enter the market with the required regulatory approval. The clearance is tied to the product code DXY and was reviewed by the Cardiovascular (CV) Advisory Committee.

Are there any specific storage instructions or handling considerations mentioned for this device?

The regulatory data does not provide explicit details on storage conditions or handling instructions for the Multi-Programmable Pacemaker & Programmer. Clinicians should follow manufacturer guidelines (provided by Medtronic Vascular) and standard medical device protocols to ensure proper storage, maintenance, and handling to preserve functionality and safety.

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: MULTI-PROGRAMMABLE PACEMAKER & PROGRMR. (K801584) — FDA 510 (k ..., Medtronic Vascular Multi-Programmable Pacemaker & Progrmr, K801584 - MULTI-PROGRAMMABLE PACEMAKER & PROGRMR. | FDA 510(k), Pacemakers | Medtronic

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K801584 24 fields · synced Oct 6, 2026