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510(k) Data Aggregation
K Number
K161427Device Name
Pirouette 035
Manufacturer
ArraVasc Limited
Date Cleared
2016-07-30
(68 days)
Product Code
LIT
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
ArraVasc Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Pirouette 035 PTA Catheter is intended for balloon of the iliac, femoral, popliteal, infra-popliteal and renal arteries.
Device Description
The Pirouette 035 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 quidewire lumen allowing the catheter to track over a quidewire 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 .035 inch (0.89 mm) wire guides. The Pirouette 035 PTA Catheter Family includes multiple balloon sizes ranging from 3 to 12 mm in diameter and 20 to 200mm in length. The nominal balloon diameter (mm) and the balloon length (mm) are inscribed on the quidewire hub of the manifold. The effective lengths of the catheter are 75cm and 130cm.
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K Number
K151153Device Name
Pirouette 018
Manufacturer
ARRAVASC LIMITED
Date Cleared
2015-08-20
(112 days)
Product Code
LIT
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
ARRAVASC LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Pirouette 018 is intended for balloon dilation of the iliac, femoral, poplitean and renal arteries.
Device Description
Percutaneous Transluminal Angioplasty Catheter (PTA Catheter).
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