Programmer, Medtronic Model 5984/5985
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K791181 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 Programmer, designed to interface with and configure implantable pacemaker systems. It provides programming capabilities for adjusting pacing parameters, diagnostic functions, and patient-specific therapy settings to ensure optimal cardiac rhythm management.
The Programmer, Medtronic Model 5984/5985 is intended for use in clinical settings by trained healthcare professionals. It is not a sterile device and is reusable, requiring proper maintenance and calibration. The device is classified as Class III under FDA regulations and holds a Traditional 510(k) clearance for substantial equivalence in the cardiovascular category. No MRI safety or sterility specifications are indicated in the provided data.
Frequently asked questions
What is the primary purpose of the Medtronic Model 5984/5985 Programmer in clinical settings?
The Medtronic Model 5984/5985 Programmer is designed to interface with implantable pacemaker systems, allowing trained healthcare professionals to adjust pacing parameters, perform diagnostic functions, and customize patient-specific therapy settings. This ensures precise cardiac rhythm management tailored to individual patient needs.
Is this device intended for single-use or can it be reused in clinical environments?
This device is not a sterile product and is explicitly labeled as reusable. It requires proper maintenance and calibration to ensure accurate and reliable performance over repeated use in clinical settings.
How is the regulatory clearance for this device categorized, and what does that mean for its use?
The Medtronic Model 5984/5985 holds a Traditional 510(k) clearance under the FDA’s Class III classification, demonstrating substantial equivalence to a predicate device in the cardiovascular category. This means it has undergone rigorous review to confirm safety and effectiveness for programming implantable pacemaker systems, ensuring compliance with U.S. regulatory standards.
Who is authorized to use this programmer, and where is it typically deployed?
This device is intended exclusively for use by trained healthcare professionals in clinical settings, such as hospitals or cardiac care facilities. Its design and functionality are tailored for specialized cardiac rhythm management applications, not for home or general medical use.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K791181 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K791181 24 fields · synced Oct 6, 2026