Permanent Pacing Lead (Refino +3 more)
FDA 510(k)Class III (US FDA 510(k))
by Oscor Inc.
Identifiers
- 510(k) Number
- K040569 FDA 510(k)
- FDA Product Code
- DTB FDA 510(k)
- Models / Variants
- Refino FDA 510(k)Model: Refino-R FDA 510(k)Ru FDA 510(k)Rju 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 Lead, Model Refino, is a cardiac device designed for transvenous implantation in the heart to provide electrical stimulation for pacing purposes. These leads are intended for use in permanent pacemaker systems, delivering consistent pacing signals to regulate abnormal heart rhythms in patients with bradycardia or other conduction disorders.
The Refino-R, RU, and RJU models are supplied sterile and intended for single-use implantation. They are classified as Class III devices under FDA regulations and require a 510(k) clearance for market authorization. Each model is compatible with standard pacemaker systems and must be implanted by a qualified healthcare professional in a controlled clinical setting, adhering to sterile techniques and manufacturer instructions.
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 | K040569 | Class III | Active |
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Manufacturer
- Manufacturer
- Oscor Inc.
- FDA Applicant
- Oscor, Inc.
Sources (1)
- FDA 510(k) K040569 24 fields · synced Sep 18, 2026