Model Rf. D&Rx..d Pacemaker Leads
FDA 510(k)Class III (US FDA 510(k))
by Oscor Inc.
Identifiers
- 510(k) Number
- K823895 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 Model RF.D&RX..D Pacemaker Leads are classified as Permanent Pacemaker Electrodes, designed for implantation in the cardiovascular system. These leads deliver electrical impulses to stimulate the heart, ensuring proper cardiac rhythm in patients with bradycardia or other conduction disorders.
These leads are intended for single-use implantation in sterile conditions, typically within an operating room or cardiac catheterization lab. They are regulated under FDA 510(k) clearance (K823895) and fall under device class III (regulation number 870.3680). Multiple reference codes (e.g., 3002618605, 2183787) identify variations in design or specifications, but all adhere to cardiovascular medical specialty standards.
Frequently asked questions
Are these pacemaker leads designed for reuse or are they intended for single-use only? Why?
These leads are explicitly designed for single-use only and must be implanted under sterile conditions, such as in an operating room or cardiac catheterization lab. The manufacturer’s description emphasizes their use in sterile environments, which aligns with single-use medical devices to prevent infection and ensure patient safety.
What types of heart conditions are these leads intended to address, and how do they work?
These leads are intended for patients with bradycardia or conduction disorders, delivering electrical impulses to stimulate the heart and maintain proper cardiac rhythm. They function as permanent pacemaker electrodes, directly interfacing with the heart tissue to regulate contractions when the natural electrical system fails.
How are these leads supplied, and what should clinicians consider when handling them?
The leads are supplied as sterile, single-use devices for direct implantation. Clinicians should ensure they are handled in a sterile field (e.g., OR or cath lab) and used immediately after opening to prevent contamination. The design ensures compatibility with pacemaker systems but requires proper aseptic technique during deployment.
What regulatory pathway was followed for these leads, and what does that mean for their use?
These leads were cleared via the FDA 510(k) process (K823895), classified under device class III (regulation 870.3680) for cardiovascular applications. This means they were deemed substantially equivalent to a predicate device and meet strict safety and performance standards for permanent pacemaker electrodes, ensuring clinical reliability and compliance with U.S. medical device regulations.
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 | K823895 | Class III | Active |
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Manufacturer
- Manufacturer
- Oscor Inc.
- FDA Applicant
- Oscor, Inc.
Sources (1)
- FDA 510(k) K823895 24 fields · synced Sep 18, 2026