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510(k) Data Aggregation
K Number
K130566Device Name
BASIXTOUCHManufacturer
Date Cleared
2013-06-19
(107 days)
Product Code
Regulation Number
870.1650Type
SpecialPanel
CardiovascularReference & Predicate Devices
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The basixTOUCH Inflation Syringe is used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.
Device Description
The basixTOUCH Inflation Syringe is a single use disposable device capable of generating and monitoring pressure in angioplasty or other similar interventional devices. It is fitted with a threaded plunger assembly with lock/release bar, flexible high pressure extension tube.
AI/ML Overview
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