Implantable Endocardial Screw-In Electrode
FDA 510(k)Class III (US FDA 510(k))
by Oscor Inc.
Identifiers
- 510(k) Number
- K791732 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)
This device is a permanent pacemaker electrode, classified under the nomenclature for endocardial leads designed for transvenous implantation. It is a screw-in type electrode intended for fixation within the endocardium, providing electrical connectivity for cardiac pacing applications. The device is engineered to ensure stable positioning and reliable signal transmission within the heart’s chambers.
The electrode is supplied sterile and intended for single-use implantation by qualified healthcare professionals in a clinical setting. It is classified as a Class III medical device under FDA regulations (870.3680) and has received FDA 510(k) clearance as substantially equivalent to predicate devices. Storage and handling must comply with sterile medical device protocols to maintain integrity prior to use.
Frequently asked questions
What is the primary purpose of this device in cardiac pacing applications?
This device is a permanent pacemaker electrode designed for transvenous implantation within the heart’s chambers. It uses a screw-in mechanism to securely fix itself to the endocardium, ensuring stable positioning and reliable electrical connectivity for pacing therapy. This helps maintain consistent heart rhythm in patients requiring chronic cardiac pacing support.
Is this device intended for reuse, or is it meant to be used only once?
The device is sterile and intended for single-use only. It must be implanted by qualified healthcare professionals in a clinical setting, and reuse is not recommended or supported by the manufacturer. Sterility must be maintained until the time of use to ensure patient safety.
How should this device be stored before use, and what precautions should be taken?
Since this is a sterile medical device, it must be stored and handled according to sterile medical device protocols to preserve its integrity. The packaging should remain unopened until immediately before use, and storage conditions should prevent contamination or damage. Always follow manufacturer guidelines for shelf life and environmental storage requirements.
What regulatory pathway was followed for FDA clearance of this device?
This device received FDA 510(k) clearance under the Traditional Review pathway, classified as a Class III medical device (product code: DTB). The clearance was granted as substantially equivalent (SESE) to predicate devices, with the Cardiovascular (CV) Advisory Committee providing oversight. The original submission was filed in 1979, with a decision made on September 19, 1979.
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 | K791732 | Class III | Active |
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Manufacturer
- Manufacturer
- Oscor Inc.
- FDA Applicant
- Oscor, Inc.
Sources (1)
- FDA 510(k) K791732 24 fields · synced Sep 18, 2026