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510(k) Data Aggregation
K Number
K981936Device Name
ABD VARISOFT STEERABLE GUIDE WIRE AND ABD VARISOFT GUIDE WIRE EXTENSION
Manufacturer
Date Cleared
2000-02-16
(624 days)
Product Code
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED BIOMEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
INTENDED USE. The VariSoft Guide Wire is intended to facilitate the placement of balloon dilatation catheters during PTCA and/or PTA. The VariSoft Guide Wire is not intended for use in the cerebral vasculature.
INTENDED USE. The ABD VariSoft Guide Wire Extension is intended to provide the necessary length to allow the exchange of one dilatation catheter for another while maintaining the position of the ABD VariSoft Steerable Guide Wire in the coronary artery. After the dilatation catheter exchange has been completed, the ABD VariSoft Guide Wire Extension can be detached and the ABD VariSoft Steerable Guide Wire can be used as a conventional steerable guide wire.
Device Description
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