Transvenous Permanent Tined Target Tip Pacing Leads
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K951858 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
- ST FDA 510(k)
This device is a Permanent Pacemaker Electrode (product code DTB), designed for transvenous implantation. It delivers electrical pacing impulses to the heart via a lead positioned through a vein, with a tined tip to secure placement within cardiac tissue and reduce dislodgement risk.
The leads are intended for permanent use in cardiac pacemaker systems and are supplied sterile for single-patient application. They comply with FDA 510(k) clearance (K951858) under Class III regulatory requirements, with no third-party reprocessing indicated. Storage and handling follow sterile medical device protocols as specified by the manufacturer.
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. Sources consulted: Transvenous Permanent Tined Target Tip Pacing Leads - Medtronic ..., TRANSVENOUS, PERMANENT TINED TARGET TIP... (K951858) - FDA 510 (k), TRANSVENOUS, PERMANENT TINED TARGET TIP... (K961679) - FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K951858 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K951858 24 fields · synced Oct 6, 2026