Model Zy Pacemaker Lead-Various
FDA 510(k)Class III (US FDA 510(k))
by Oscor Inc.
Identifiers
- 510(k) Number
- K823890 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 ZY Pacemaker Lead is a Permanent Pacemaker Electrode, designed to establish an electrical connection between a cardiac pacemaker and the heart muscle. It facilitates rhythmic electrical stimulation to regulate heart rate in patients with bradycardia or conduction disorders, ensuring proper cardiac function.
This device is intended for single-use in clinical settings, supplied sterile, and falls under FDA regulation 870.3680. It was granted FDA 510(k) clearance (K823890) under the DTB product code, classified as a Class III device. Multiple model variants are listed, including reference numbers such as 3002618605, 3008377825, and others, reflecting its regulatory compliance and availability in various configurations.
Frequently asked questions
What is the primary purpose of the Model ZY Pacemaker Lead, and how does it function in the body?
The Model ZY Pacemaker Lead is designed to establish an electrical connection between a cardiac pacemaker and the heart muscle. It delivers rhythmic electrical impulses to regulate heart rate in patients with bradycardia (slow heart rate) or conduction disorders, ensuring the heart maintains proper function.
Is this device intended for single-use or can it be reused? How is it supplied?
The Model ZY Pacemaker Lead is explicitly intended for single-use in clinical settings. It is supplied sterile, meaning it is packaged and ready for immediate use without additional sterilization.
What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?
The Model ZY Pacemaker Lead received FDA 510(k) clearance (K823890) under the Traditional clearance type, classified as a Class III medical device. It was determined to be *substantially equivalent* to a predicate device and falls under FDA regulation 870.3680 for permanent pacemaker electrodes.
Are there multiple model variants available, and how can I identify them?
Yes, the Model ZY Pacemaker Lead is available in multiple configurations, each with unique FEI (Final Establishment Identification) numbers such as 3002618605, 3008377825, or 3003574398. These identifiers help distinguish between different variants while maintaining compliance with regulatory requirements.
What advisory committee reviewed this device submission, and what medical specialty does it pertain to?
The submission for the Model ZY Pacemaker Lead was reviewed by the Cardiovascular (CV) Advisory Committee, reflecting its relevance to cardiovascular medicine. The device is categorized under the medical specialty description
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: MODEL ZY PACEMAKER LEAD-VARIOUS (K823890) — FDA 510 (k) | Innolitics, Model ZY Pacemaker Lead - Oscor | FDA Reference, PDF K823890 - Model Zy Pacemaker Lead-various, MODEL ZY PACEMAKER LEAD-VARIOUS 510 (k) K823890 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K823890 | Class III | Active |
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Manufacturer
- Manufacturer
- Oscor Inc.
- FDA Applicant
- Oscor, Inc.
Sources (1)
- FDA 510(k) K823890 24 fields · synced Sep 18, 2026