Cardiac Pulse Generators 5982/5983
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K771786 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 Cardiac Pulse Generators 5982/5983 are implantable pacemaker pulse-generators, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. These devices are intended for patients with bradycardia or other conduction disorders requiring consistent pacing stimulation to maintain proper heart function.
These pulse-generators are supplied as implantable, reusable devices and are regulated under FDA 510(k) clearance (K771786) as substantially equivalent to predicate devices. They are classified as Class III medical devices under the FDA’s regulatory framework, requiring strict adherence to manufacturing and performance standards. Storage and handling follow sterile implant protocols, and their use is governed by cardiovascular specialty guidelines.
Frequently asked questions
Are these pulse generators intended for single-use or can they be reused after implantation?
These Cardiac Pulse Generators 5982/5983 are designed as reusable implantable devices. Since they are intended for long-term cardiac rhythm regulation, they are not single-use and are meant to remain implanted in the patient for extended periods, following sterile implant protocols.
What types of patients are these devices primarily intended to support?
These pulse generators are specifically designed for patients with bradycardia or conduction disorders that require consistent pacing stimulation. They regulate cardiac rhythm by delivering electrical impulses to maintain proper heart function in individuals whose natural conduction system is insufficient.
How are these devices stored and handled before implantation?
Since these are implantable devices, they must be stored and handled under sterile conditions to ensure patient safety. The manufacturer follows strict sterile implant protocols, as required for Class III medical devices, to prevent contamination before use.
What regulatory pathway was followed for FDA clearance of these pulse generators?
These devices were cleared through the FDA’s 510(k) pathway under the classification of Traditional Review, with a decision code of SESE (Substantially Equivalent). The submission was reviewed by the Cardiovascular (CV) Advisory Committee and classified as Class III, requiring compliance with strict manufacturing and performance standards.
Are there multiple models or sizes available for these pulse generators?
The provided data does not specify distinct sizes or models beyond the two listed product codes (5982/5983). However, the OpenFDA registration numbers suggest multiple lot or batch identifiers, which may correspond to variations in manufacturing or batch-specific details. For exact sizing or model variations, refer to the manufacturer’s technical documentation.
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 | K771786 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K771786 24 fields · synced Oct 6, 2026