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510(k) Data Aggregation
K Number
K132545Device Name
MEDIVALVE ACWIRE
Manufacturer
Date Cleared
2013-11-08
(87 days)
Product Code
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
MEDIVALVE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ac Wire is intended for use in peripheral vascular and heart catheterization procedures to introduce and assist in positioning diagnostic and interventional devices. The ac Wire may also function as an alignment tool by providing a reference plane of anatomical structures of interest (e.g., the aortic valve).
Device Description
The ac Wire device is a 0.035"" outside diameter, single use, disposable guidewire. The ac Wire device consists of a flexible guidewire that incorporates a low profile, radiopaque alignment element consisting of three loops with radiopaque markers that when open, form a "tulip" configuration designed to assist the physician in acquiring a reference plane under fluoroscopy.
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