Permanent Pacing Leads, Models Physique PB and PJB
FDA 510(k)Class III (US FDA 510(k))
by Oscor Inc.
Identifiers
- 510(k) Number
- K024053 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 Permanent Pacing Leads, Models Physique PB and PJB, are classified as Permanent Pacemaker Electrodes. These devices are designed to deliver electrical impulses to the heart, facilitating proper cardiac rhythm regulation in patients with bradycardia or other pacing-dependent conditions. They are intended for implantation within the cardiac chambers to ensure reliable electrical conduction and pacing functionality over an extended period.
These leads are supplied sterile and intended for single-use implantation in clinical settings such as cardiac catheterization labs or operating rooms. They are regulated under FDA 510(k) clearance with a classification of Class III, adhering to strict manufacturing and quality control standards. The Physique PB and PJB models are available in specific configurations for right atrial, right ventricular, or biventricular pacing applications, with sizes and designs tailored for compatibility with various pacemaker systems. Storage requires adherence to sterile packaging guidelines to maintain integrity until use.
Frequently asked questions
Are these pacing leads reusable, or are they intended for single-use only in clinical settings?
These leads are explicitly designed for single-use implantation in clinical environments like cardiac catheterization labs or operating rooms. They are supplied sterile in their packaging, ensuring they remain uncontaminated until use, which aligns with standard practices for permanent pacing leads to prevent infection and ensure reliability.
What types of pacing applications are the Physique PB and PJB leads configured for?
The Physique PB and PJB leads are tailored for right atrial, right ventricular, or biventricular pacing applications, depending on the model. Their designs are optimized for compatibility with various pacemaker systems to deliver electrical impulses effectively in patients requiring cardiac rhythm regulation for conditions like bradycardia.
How should these leads be stored to maintain their sterility and integrity?
Storage must follow the manufacturer’s guidelines for sterile packaging integrity. The leads should remain in their original, unopened packaging until ready for use, protected from contamination or physical damage. This ensures they meet the sterile requirements for implantation and maintain their functionality.
What regulatory pathway was followed for FDA clearance of these leads?
These leads were cleared through the FDA 510(k) pathway, specifically under a Special Clearance Type with a decision code of SESE (Substantially Equivalent). The submission was reviewed by the Cardiovascular (CV) Advisory Committee, reflecting their classification as Class III devices under regulation number 870.3680 for permanent pacemaker electrodes.
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 | K024053 | Class III | Active |
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Manufacturer
- Manufacturer
- Oscor Inc.
- FDA Applicant
- Oscor, Inc.
Sources (1)
- FDA 510(k) K024053 24 fields · synced Sep 18, 2026