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510(k) Data Aggregation
K Number
K222631Device Name
VASSALLO GT EXT
Manufacturer
Date Cleared
2022-10-26
(56 days)
Product Code
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
Filmecc Co. Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The VASSALLO GT EXT guide wire accessory is intended for extension of the working length of an already introduced guide wire when exchanging over-the-wire interventional devices during an angioplasty procedure. This device is intended for peripheral vascular use only.
Device Description
The VASSALLO GT EXT Guide Wire Extension accessory is used to elongate the working length of compatible peripheral extendable wires. The stainless-steel guide wire extension has an outer diameter of 0.014" (0.36 mm) and a length of 165 cm. The distal end consists of a pipe shaped nitinol-titanium connection port (extension tube). The straight stainless steel wire surface is coated with PTFE. The extension wire is intended to connect with a FILMECC peripheral guide wire shorter than 300 cm. The total length of the system after connection will be 300 cm to 400 cm.
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