Medtronic Pacing Leads and Lead Adaptors, Modif
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K933055 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
- PT FDA 510(k)
The Medtronic Pacing Leads and Lead Adaptors are classified as Permanent Pacemaker Electrodes, designed to transmit electrical impulses from a pacemaker to the heart muscle. These components are integral to maintaining proper cardiac rhythm in patients requiring pacing support.
These devices are supplied as part of a cardiac pacing system and are intended for single-use applications. They are regulated under FDA 510(k) clearance (K933055) and fall under Class III medical devices, adhering to regulatory standards for cardiovascular applications. The product code DTB categorizes these leads and adaptors for tracking and post-market surveillance.
Frequently asked questions
Are these pacing leads designed for reuse in multiple patients, or are they intended for single-use only?
These leads are explicitly intended for single-use applications only. The device description confirms they are part of a cardiac pacing system meant to be used once per patient, ensuring patient safety and sterility standards.
What regulatory pathway was followed for FDA clearance of these pacing leads and adaptors?
The device received FDA 510(k) clearance (K933055) under the Traditional 510(k) Review pathway, with a decision of Substantially Equivalent and subject to tracking and post-market surveillance. It falls under Class III classification and was reviewed by the Cardiovascular (CV) Advisory Committee.
How are these leads categorized for tracking and regulatory purposes?
These leads and adaptors are assigned the product code DTB, which is used for tracking and post-market surveillance by the FDA. This categorization aligns with their classification as Permanent Pacemaker Electrodes under the Cardiovascular medical specialty.
What types of cardiac pacing systems are these leads compatible with?
While the data does not specify exact system compatibility, these leads are integral components of permanent pacemaker systems designed to transmit electrical impulses to the heart muscle. They are supplied as part of a broader cardiac pacing solution, meaning they are intended for use with Medtronic’s pacemaker devices (though exact models are not detailed).
Are there multiple sizes or models of these pacing leads, and if so, how are they identified?
The data lists multiple FEI (Firmware/Equipment Identification) numbers (e.g., 3002618605, 2183787, etc.), which likely correspond to different sizes, models, or configurations of the leads and adaptors. These identifiers are used for regulatory tracking rather than clinical labeling, but they indicate variability in the product line for different patient needs.
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: Medtronis R Pacing Leads and Lead Adaptors - Medtronic Vascular | FDA ..., Medtronis(R) Pacing Leads and Lead Adaptors, Modif (K933055) — Fda 510 ..., K933055 FDA 510(k) - MEDTRONIS PACING LEADS AND LEAD ADAPTORS, Medtronis (R) Pacing Leads and Lead Adaptors, Modif
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K933055 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K933055 24 fields · synced Oct 6, 2026