Implantable Endocardial Pacing Leads
FDA 510(k)Class III (US FDA 510(k))
by Oscor Inc.
Identifiers
- 510(k) Number
- K831997 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 Endocardial Pacing Leads are classified as Permanent Pacemaker Electrodes, designed for direct electrical stimulation of the heart’s endocardium. These leads are intended for use within implantable pacemaker systems to regulate cardiac rhythm by delivering timed electrical impulses to the heart muscle, ensuring proper pacing and synchronization of contractions.
These leads are supplied sterile and intended for single-use implantation via surgical procedures in a controlled clinical setting. They are categorized under FDA device class 3 and comply with regulation number 870.3680, with multiple FEI numbers (e.g., 2017865, 3002618605) registered under the Cardiovascular specialty. Storage and handling must adhere to sterile medical device protocols to maintain integrity prior to use.
Frequently asked questions
Are these leads designed for reuse in multiple patients, or are they intended for single-use only?
These leads are explicitly intended for single-use only after implantation. The manufacturer specifies they are supplied sterile and must be used in a controlled clinical setting via surgical procedures, which aligns with standard sterile medical device protocols for one-time use.
What types of storage conditions should be followed to maintain the leads’ sterility before use?
The leads must be stored and handled according to sterile medical device protocols to preserve their integrity. Since they are supplied sterile and intended for single-use, proper packaging and environmental controls (e.g., clean, dry, and protected from contamination) are critical before opening and implantation.
What is the primary purpose of these leads in a clinical setting?
These leads are permanent pacemaker electrodes designed to deliver timed electrical impulses directly to the heart’s endocardium. Their purpose is to regulate cardiac rhythm by ensuring proper pacing and synchronization of heart contractions within an implantable pacemaker system.
How are these leads categorized under FDA regulations, and what does that mean for their use?
These leads fall under FDA device class 3, regulated under 870.3680, and are classified as *Permanent Pacemaker Electrodes*. This classification means they undergo rigorous review (e.g., 510(k) clearance) to ensure safety and effectiveness for their intended use in cardiac pacing systems, requiring compliance with strict manufacturing and performance standards.
What are the key differences between these leads and other pacing leads, based on their design and intended use?
Unlike some pacing leads that may target other cardiac regions (e.g., epicardial), these are endocardial leads, meaning they are specifically designed for direct electrical stimulation of the inner heart lining. Their placement ensures precise pacing for rhythm regulation, which is critical for patients requiring chronic cardiac support via implantable pacemakers.
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 | K831997 | Class III | Active |
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Manufacturer
- Manufacturer
- Oscor Inc.
- FDA Applicant
- Oscor, Inc.
Sources (1)
- FDA 510(k) K831997 24 fields · synced Sep 18, 2026