Model Sf. D&Sx.d Pacemaker Leads
FDA 510(k)Class III (US FDA 510(k))
by Oscor Inc.
Identifiers
- 510(k) Number
- K823897 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 SF.D&SX.D Pacemaker Leads are classified as Permanent Pacemaker Electrodes, designed to deliver electrical impulses to the heart for the treatment of cardiac rhythm disorders. These leads are implanted within the cardiovascular system to stimulate the heart muscle, ensuring proper pacing and coordination of contractions in patients with bradycardia or other conduction abnormalities.
These leads are intended for single-use implantation in cardiac pacing procedures and are supplied sterile. They are regulated under the FDA’s 510(k) pathway with a Traditional clearance, classified as Class III medical devices. The Model SF.D&SX.D is authorized for use in cardiovascular settings and adheres to regulatory standards outlined in 21 CFR 870.3680, with no specific MRI safety labeling indicated.
Frequently asked questions
Are these pacemaker leads designed for reuse in multiple patients, or are they intended for single-use only?
The Model SF.D&SX.D Pacemaker Leads are explicitly intended for single-use implantation in cardiac pacing procedures. This is clearly stated in the device description, which specifies they are supplied sterile and meant for one-time use during surgery.
What types of cardiac rhythm disorders are these leads authorized to treat?
While the device description mentions these leads are designed to deliver electrical impulses for bradycardia or conduction abnormalities, the exact clinical indications are not detailed beyond their role in stimulating the heart muscle to ensure proper pacing and coordination. The authorization focuses on their function as permanent pacemaker electrodes, not specific diagnoses.
How should these leads be stored before use, and what sterility assurance is provided?
The leads are supplied sterile, but the specific storage instructions (e.g., temperature, humidity, or packaging requirements) are not detailed in the provided data. However, since they are single-use and sterile upon packaging, proper storage would typically involve maintaining the manufacturer’s recommended conditions to preserve sterility until implantation.
What regulatory pathway was used for FDA clearance, and what does that mean for clinical use?
The Model SF.D&SX.D Pacemaker Leads were cleared via the FDA’s 510(k) pathway with a Traditional clearance, classified as a Class III medical device. This means the manufacturer demonstrated substantial equivalence to a legally marketed predicate device, ensuring compliance with regulatory standards (e.g., 21 CFR 870.3680) for safety and effectiveness in treating cardiac rhythm disorders.
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 | K823897 | Class III | Active |
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Manufacturer
- Manufacturer
- Oscor Inc.
- FDA Applicant
- Oscor, Inc.
Sources (1)
- FDA 510(k) K823897 24 fields · synced Sep 18, 2026