Oscor Permanent Pacing Lead RZ Model Series
FDA 510(k)Class III (US FDA 510(k))
by Oscor Inc.
Identifiers
- 510(k) Number
- K003918 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
- ST FDA 510(k)
The Oscor Permanent Pacing Lead RZ Model Series is a Permanent Pacemaker Electrode, designed for transvenous implantation in the heart to provide electrical stimulation for pacing purposes. These leads are intended for use with implantable pulse generators to treat bradycardia or other cardiac rhythm disorders by delivering consistent pacing signals to the right atrium or ventricle.
The leads are supplied sterile and intended for single-use implantation in clinical settings such as cardiac catheterization labs or electrophysiology suites. They are classified as Class III devices under FDA regulations and are subject to 510(k) clearance with tracking requirements. Various model references are available, ensuring compatibility with different pacing systems, and storage follows standard sterile medical device protocols to maintain integrity until use.
Frequently asked questions
What is the primary purpose of the Oscor Permanent Pacing Lead RZ Model Series in clinical settings?
The Oscor Permanent Pacing Lead RZ Model Series is designed for transvenous implantation in the heart to deliver electrical stimulation via an implantable pulse generator. It is specifically intended to treat bradycardia or other cardiac rhythm disorders by providing consistent pacing signals to either the right atrium or ventricle, ensuring reliable cardiac function.
Are these leads reusable, or are they intended for single-use only?
These leads are supplied sterile and explicitly intended for single-use implantation in clinical settings like cardiac catheterization labs or electrophysiology suites. Reuse is not recommended or supported by the manufacturer.
How should the Oscor Permanent Pacing Lead RZ Model Series be stored to maintain sterility?
The leads follow standard sterile medical device protocols for storage. They should be kept in their original packaging until use, ensuring the sterile barrier remains intact to preserve integrity and prevent contamination.
What types of pacing systems are compatible with the Oscor Permanent Pacing Lead RZ Model Series?
The RZ Model Series includes multiple model references, each designed for compatibility with different implantable pulse generators. While exact system compatibility isn’t detailed here, the variety of model references ensures flexibility for clinicians selecting leads for specific pacing systems.
What regulatory pathway was followed for FDA clearance of this device?
The Oscor Permanent Pacing Lead RZ Model Series underwent a 510(k) clearance process through the FDA, classified as a Class III device under 21 CFR 870.3680. It was determined to be *substantially equivalent* to a predicate device and is subject to tracking requirements, as indicated by the advisory committee designation (CV) and traditional clearance type.
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 | K003918 | Class III | Active |
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Manufacturer
- Manufacturer
- Oscor Inc.
- FDA Applicant
- Oscor, Inc.
Sources (1)
- FDA 510(k) K003918 24 fields · synced Sep 18, 2026