Reprocessed Electrophysiology Catheters
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K043392 FDA 510(k)
- FDA Product Code
- NLH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1220 FDA 510(k)
- Regulation Number
- 870.1220 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Reprocessed Electrophysiology Catheters are electrode recording catheters designed for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures. These devices facilitate the diagnostic evaluation of cardiac electrical activity.
This device is regulated under FDA 510K clearance number K043392. It is classified as a reprocessed electrode recording catheter for cardiovascular use.
Frequently asked questions
What is the clinical purpose of the Reprocessed Electrophysiology Catheters?
These catheters are designed for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures to facilitate the diagnostic evaluation of cardiac electrical activity.
What is the regulatory status of these reprocessed catheters?
This device is regulated under FDA 510K clearance number K043392, which confirms it has been found substantially equivalent to predicate devices for its intended use in cardiovascular procedures.
How are these catheters classified for medical use?
The device is classified as a reprocessed electrode recording catheter for cardiovascular use, falling under regulation number 870.1220 and product code NLH.
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: REPROCESSED ELECTROPHYSIOLOGY CATHETER by ALLIANCE MEDICAL CORP. | FDA ..., K030279 FDA 510(k) - REPROCESSED ELECTROPHYSIOLOGY CATHETER, REPROCESSED ELECTROPHYSIOLOGY CATHETER 510(k) K030187 - fda.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K043392 | Class II | Active |
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Manufacturer
- Manufacturer
- Alliance Medical, Inc.
- FDA Applicant
- Alliance Medical Corp.
Sources (1)
- FDA 510(k) K043392 24 fields · synced Oct 6, 2026