Model JY Pacemaker Lead
FDA 510(k)Class III (US FDA 510(k))
by Oscor Inc.
Identifiers
- 510(k) Number
- K823889 FDA 510(k)
- FDA Product Code
- DTB FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3680 FDA 510(k)
- Regulation Number
- 870.3680 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Model JY Pacemaker Lead is a Permanent Pacemaker Electrode, designed to deliver electrical impulses to the heart for the treatment of bradycardia or other cardiac rhythm disorders. It is intended for implantation within the cardiac chambers to stimulate contractions and maintain proper heart function in patients requiring pacemaker therapy.
This lead is supplied sterile and intended for single-use implantation by qualified medical professionals in clinical settings such as cardiac catheterization labs or operating rooms. It is classified as a Class III device under FDA regulations and has received FDA 510(k) clearance as substantially equivalent to predicate devices. Multiple model variants are available, each with distinct specifications for compatibility with various pacemaker systems.
Frequently asked questions
What types of cardiac rhythm disorders is this pacemaker lead designed to treat, and how does it work?
The Model JY Pacemaker Lead is specifically designed to treat bradycardia and other cardiac rhythm disorders by delivering electrical impulses to the heart. It stimulates contractions in the cardiac chambers to maintain proper heart function in patients requiring pacemaker therapy. The lead is implanted within the heart to ensure consistent electrical stimulation, helping regulate an irregular or slow heartbeat.
Is this lead intended for reuse, or is it meant to be used only once after implantation?
This lead is sterile and intended for single-use only. It must be implanted by qualified medical professionals in controlled settings like cardiac catheterization labs or operating rooms, ensuring patient safety and sterility standards are met.
How many model variants are available, and what determines their compatibility with different pacemaker systems?
Multiple model variants of the Model JY Pacemaker Lead are available, each designed with distinct specifications to ensure compatibility with various pacemaker systems. The differences in design allow for tailored use depending on the specific requirements of the patient’s pacemaker setup.
What kind of regulatory clearance does this device have, and how was it determined?
The Model JY Pacemaker Lead has received FDA 510(k) clearance, classified as substantially equivalent to predicate devices under the Traditional 510(k) review pathway. It was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee and falls under Class III device regulations, indicating its critical role in treating life-threatening conditions like bradycardia.
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 | K823889 | Class III | Active |
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Manufacturer
- Manufacturer
- Oscor Inc.
- FDA Applicant
- Oscor, Inc.
Sources (1)
- FDA 510(k) K823889 24 fields · synced Sep 18, 2026