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510(k) Data Aggregation
K Number
K222182Device Name
Radial Artery Compression TourniquetsManufacturer
Date Cleared
2023-01-04
(166 days)
Product Code
Regulation Number
870.4450Type
TraditionalPanel
CardiovascularReference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Radial Artery Compression Tourniquet is designed for temporary hemostasis of radial artery post percutaneous puncture.
Device Description
Radial Artery Compression Tourniquets
AI/ML Overview
The provided document is a 510(k) clearance letter for the "Radial Artery Compression Tourniquets" and does not contain the specific information about acceptance criteria, device performance, study details, or AI-related data as requested. This letter confirms that the device is substantially equivalent to a predicate device and can be marketed, but does not include the detailed technical study information you're looking for.
Therefore, I cannot provide the requested information based on the input text.
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