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510(k) Data Aggregation
K Number
K073025Device Name
VASCUTRAK II PTA DILATATION CATHETER
Manufacturer
THERMOPEUTIX INC. DBA YMED INC.
Date Cleared
2007-11-09
(14 days)
Product Code
PNO
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
THERMOPEUTIX INC. DBA YMED INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VascuTraK™ II PTA Dilatation Catheter is intended for dilatation of stenoses in the peripheral arteries including the iliac, femoral, popliteal, ilio-femoral, infrapopliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Device Description
The VascuTraK™ II Catheter is a sterile single use device that consists of a flexible shaft with a single through lumen terminating in a semi-compliant balloon. The catheter has a 24 cm lumen proximal to the balloon that accepts a 0.014" guidewire and an 18 mm lumen distal to the balloon that accepts a 0.014" guidewire. The distal balloon is inflated via a central lumen terminated in a luer fitting at the proximal end. The balloon is available in various diameters and lengths,
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