Implantable Cardiac Pacing Leads
FDA 510(k)Class III (US FDA 510(k))
by Oscor Inc.
Identifiers
- 510(k) Number
- K831767 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 Implantable Cardiac Pacing Leads are classified as Permanent Pacemaker Electrodes, designed for chronic cardiac pacing applications. These leads are intended for implantation within the heart to stimulate cardiac muscle contraction, ensuring proper heart rhythm in patients with bradycardia or conduction system disorders.
These leads are supplied sterile and intended for single-use implantation. They are regulated under FDA 510(k) clearance (K831767) and fall under Device Type DTB, Class III, with regulatory number 870.3680. Multiple model references are available, including 3002618605, 3008377825, and others, ensuring compatibility with various pacemaker systems. Storage and handling must adhere to sterile medical device protocols.
Frequently asked questions
Are these pacing leads designed for temporary or chronic use in patients?
These leads are specifically designed for chronic cardiac pacing applications, meaning they are intended for long-term implantation to maintain proper heart rhythm in patients with bradycardia or conduction system disorders. They are not temporary leads, which are typically used for short-term monitoring or stabilization.
How many different model references are available for these leads, and what should I consider when selecting one?
Over 15 distinct model references are listed, including examples like 3002618605 and 3008377825. Selection should be based on compatibility with your chosen pacemaker system, as these leads are designed to work with various pacemaker platforms. Always verify compatibility with your device manufacturer’s specifications before ordering.
Are these leads reusable, or are they intended for single-use only?
These leads are intended for single-use only and are supplied sterile. Reuse is not recommended or supported, as it could compromise sterility and patient safety. Proper sterile handling and disposal protocols must be followed to maintain clinical standards.
What storage and handling precautions should I take with these leads?
Since these leads are sterile, they must be stored and handled according to standard sterile medical device protocols. This includes keeping them in their original packaging until immediately before use, protecting them from contamination, and adhering to manufacturer guidelines for shelf life and environmental conditions (e.g., temperature, humidity). Always check the packaging for expiration dates.
What regulatory pathway was followed for FDA clearance of these leads, and which advisory committee was involved?
These leads were cleared through the FDA 510(k) pathway under the traditional review process, with a decision of Substantially Equivalent (SESE). The review was conducted by the Cardiovascular (CV) Advisory Committee, reflecting their specialized expertise in cardiac devices. The clearance number is K831767, and they fall under Class III regulatory classification (DTB, product code 870.3680).
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: PDF Product Portfolio - Implantable cardiac pacing leads, introducer ..., Endocardial & Epicardial implantable pacing leads - OSCOR, Implantable cardiac pacing leads, introducer systems and diagnostic ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K831767 | Class III | Active |
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Manufacturer
- Manufacturer
- Oscor Inc.
- FDA Applicant
- Oscor, Inc.
Sources (1)
- FDA 510(k) K831767 24 fields · synced Sep 18, 2026