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510(k) Data Aggregation
K Number
K082343Device Name
VASCUTRAK 2, MODELS: V14 AND V18
Manufacturer
YMED INC.
Date Cleared
2008-09-11
(27 days)
Product Code
PNO
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
YMED INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VascuTraK™ 2 PTA Dilatation Catheter is intended for dilatation of stenoses in the peripheral arteries including the illiac, femoral, poplited, illio-femoral, infrapopliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Device Description
The YMed VascuTraK™ 2 PTA Dilatation Catheter is a modification to the VascuTraK™ 2 PTA Dilatation Catheter cleared under K073025. The device is fabricated of the same materials as the unmodified device and has the same intended use. The distal balloon sizes for the modified device include diameters from 5.0 - 7.0 mm and lengths up to 300mm.
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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) :
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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K Number
K063657Device Name
VASCUTRAK PTA DILATION CATHETER
Manufacturer
YMED INC.
Date Cleared
2006-12-12
(4 days)
Product Code
PNO
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
YMED INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VascuTraK™ 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™ Catheter is a sterile single use device that consists of a flexible shaft with a single through lumen and a 24 cm distal lumen that accepts a 0.014" guidewire. The distal end of the catheter contains a semi-compliant balloon that is inflated via the central lumen. The balloon is available in various diameters and lengths,
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