Model 6492 Unipolar Temporary Atrial Pacing Lead
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K012458 FDA 510(k)
- FDA Product Code
- LDF FDA 510(k)
Classification
- Device Class
- Class II 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 6492 Unipolar Temporary Atrial Pacing Lead is a temporary pacing lead designed for temporary atrial pacing and sensing. It consists of an electrode and insulated multi-filament conductor crimped together, featuring a blue monofilament coil for myocardial fixation.
The device is supplied sterile and intended for single use only, with a contemplated implant duration of 7 days or less. It is regulated under product code LDF and has FDA 510K clearance, with a regulation number of 870.3680.
Frequently asked questions
What is the Model 6492 Unipolar Temporary Atrial Pacing Lead used for?
The Model 6492 is used for temporary atrial pacing and sensing, with a contemplated implant duration of 7 days or less.
Is the Model 6492 supplied sterile?
Yes, the Model 6492 is supplied sterile and is intended for single use only.
What is the product code for the Model 6492?
The product code for the Model 6492 is LDF, and it is regulated under this code with a regulation number of 870.3680.
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: Medtronic Temporary Sensing and Pacing Leads, MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD (K012458) — FDA 510 (k ..., Unipolar Atrial Temporary Pacing Lead,Model 6492
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K012458 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K012458 24 fields · synced Oct 6, 2026