Temporary Myocardial Pacing Lead #6400
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K810333 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 Temporary Myocardial Pacing Lead, classified as a Permanent Pacemaker Electrode under regulatory nomenclature. It is designed to provide temporary electrical stimulation to the heart muscle, facilitating pacing in patients requiring short-term cardiac support during procedures or recovery.
The Temporary Myocardial Pacing Lead #6400 is intended for single-use in clinical settings such as cardiac catheterization labs or emergency rooms. It is supplied sterile and is regulated under FDA 510(k) clearance (K810333) as substantially equivalent to the predicate device. Compliance with medical specialty standards for cardiovascular applications is noted in regulatory filings.
Frequently asked questions
What is the Temporary Myocardial Pacing Lead #6400 used for in clinical settings?
The Temporary Myocardial Pacing Lead #6400 is designed to provide temporary electrical stimulation to the heart muscle, supporting short-term cardiac pacing during procedures or recovery in patients who need brief cardiac support. It is intended for use in settings like cardiac catheterization labs or emergency rooms where temporary pacing is required.
Is the Temporary Myocardial Pacing Lead #6400 meant for single-use or can it be reused?
The device is explicitly labeled for single-use only in clinical settings. This ensures patient safety and sterility, as it is supplied sterile and intended for one-time use during temporary pacing procedures.
How is the Temporary Myocardial Pacing Lead #6400 regulated, and what does that mean for its use?
The device holds FDA 510(k) clearance (K810333), meaning it has been determined *substantially equivalent* to a predicate device under the regulatory pathway for cardiovascular applications. This clearance confirms it meets U.S. safety and performance standards for temporary myocardial pacing leads, ensuring compliance with medical specialty guidelines for cardiac support.
Are there different sizes or models of the Temporary Myocardial Pacing Lead #6400, or is it a single configuration?
The provided data does not specify distinct sizes or models for the #6400 lead, but it is classified under the broader category of *Permanent Pacemaker Electrodes* (FDA device class 3) with multiple associated registration numbers. For exact sizing or model variations, consult the manufacturer’s technical documentation or catalog, as these details are not detailed in the regulatory filings.
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 | K810333 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K810333 24 fields · synced Oct 6, 2026