Pulse Generator Models 5920/5921
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K780809 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, designed to provide electrical stimulation to regulate heart rhythm in patients with bradycardia or other cardiac conduction disorders. It delivers timed electrical impulses to the heart via leads, ensuring consistent pacing and maintaining proper cardiac function.
The Pulse Generator Models 5920/5921 are intended for surgical implantation and are classified as Class III medical devices under FDA regulations. They are single-use devices, supplied sterile and intended for use in controlled clinical environments. Authorized under FDA 510K clearance (K780809), these generators are regulated under 21 CFR 870.3610 and are distributed exclusively for cardiovascular applications.
Frequently asked questions
Are these pulse generators reusable or designed for single-use only, and how does that affect their handling in the operating room?
The Medtronic Vascular Pulse Generator Models 5920/5921 are explicitly labeled as single-use devices. This means they are intended for one-time surgical implantation and should not be reused or reprocessed. The sterile packaging ensures they are ready for immediate use in controlled clinical environments, reducing the risk of contamination and ensuring patient safety during implantation.
What types of cardiac conditions are these pulse generators approved to address, and how do they function?
These pulse generators are designed to treat bradycardia and other cardiac conduction disorders by delivering timed electrical impulses to the heart via leads. They regulate heart rhythm by ensuring consistent pacing, which helps maintain proper cardiac function in patients with slow or irregular heartbeats. The device is not intended for other cardiac conditions unless explicitly stated in updated documentation.
How are these devices supplied, and what should clinicians verify before use in the operating room?
The Pulse Generator Models 5920/5921 are supplied sterile and ready for surgical implantation. Clinicians should verify the sterility seal is intact and the device has not been opened or exposed to contamination before use. Since they are single-use, they must be handled with sterile techniques to prevent infection and ensure proper functionality during implantation.
What regulatory pathway was followed for FDA clearance, and what does that mean for clinicians or buyers?
These devices were cleared through the FDA 510K pathway (K780809), with a traditional review by the Cardiovascular (CV) Advisory Committee. The clearance is based on substantial equivalence to a predicate device, meaning they meet the same performance standards as previously approved pacemaker pulse generators. Clinicians or buyers can rely on this pathway as evidence of regulatory compliance for 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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K780809 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K780809 24 fields · synced Oct 6, 2026