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510(k) Data Aggregation
K Number
K172033Device Name
Pirouette High Pressure (HP)
Manufacturer
ArraVasc Ltd
Date Cleared
2017-08-31
(57 days)
Product Code
LIT
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
ArraVasc Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Pirouette High Pressure (HP) PTA Catheter is intended for balloon dilation of the iliac, femoral, popliteal, renal arteries, Arterio-venous Fistula (AVF) and Arterio-venous Graft (AVG).
Device Description
The Pirouette High Pressure (HP) Percutaneous Transluminal Angioplasty (PTA) Catheter Family are standard over the wire (OTW), semi-compliant, coaxial design catheters with a balloon mounted on the distal tip. The distal portion of the catheter has a hydrophilic coating. The manifold connector and shaft design consists of a guidewire lumen allowing the catheter to track over a guidewire and an inflation lumen, used to inflate and deflate the balloon. Radiopaque markers are positioned on the shaft within the balloon to enable visualisation of the catheter/balloon under fluoroscopy. The catheter is compatible with 0.018-inch (0.46 mm) wire guides. The Pirouette High Pressure (HP) PTA Catheter Family includes multiple balloon sizes ranging from 4 to 6 mm in diameter and 20 to 80mm in length. The nominal balloon diameter (mm) and the balloon length (mm) are inscribed on the guidewire hub of the manifold. The effective lengths of the balloon range from 45cm to 75cm.
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K Number
K162316Device Name
Pirouette 014
Manufacturer
ArraVasc Ltd
Date Cleared
2016-11-22
(96 days)
Product Code
LIT
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
ArraVasc Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pirouette 014 PTA Catheter is intended for balloon dilation of the illac, femoral, popliteal, and renal arteries.
Device Description
The Pirouette 014 Percutaneous Transluminal Angioplasty (PTA) Catheter Family are standard over the wire (OTW), semi-compliant, coaxial design catheters with a balloon mounted on the distal tip. The distal portion of the catheter has a hydrophilic coating.
The manifold connector and shaft design consists of a guidewire lumen allowing the catheter to track over a guidewire and an inflation lumen, used to inflate and deflate the balloon. Radiopaque markers are positioned on the shaft within the balloon to enable visualization of the catheter/balloon under fluoroscopy. The catheter is compatible with .014 inch (0.356 mm) wire guides.
The Pirouette 014 PTA Catheter Family includes multiple balloon sizes ranging from 1.25 mm to 4.0 mm in diameter and 15 mm to 300 mm in length. The nominal balloon diameter (mm) and the balloon length (mm) are inscribed on the guidewire hub of the manifold. The effective lengths of the catheter are 90 cm, 130 cm and 150 cm.
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