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510(k) Data Aggregation
K Number
K151896Device Name
Houdini Catheter
Manufacturer
Date Cleared
2015-12-07
(150 days)
Product Code
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Cruzar Medsystems, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Cruzar Medsystems Houdini Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.
The Houdini Catheter is indicated for use in the illac, femoral, ilio-femoral and popliteal arteries.
Device Description
The Houdini Catheter is a single use, dual-lumen intravascular catheter intended for percutaneous use. It is designed for use in conjunction with a 0.014" - 0.035" quide wire to gain access to locations within the cardiovascular system that are remote from the site of insertion. Once accessed, quide wires may be exchanged within the catheter. In addition, the Houdini Catheter can provide distal anchoring and supports the advancement of the guidewire.
The effective length of the Houdini Catheter is a nominal 100cm. The distal tip incorporates a radiopaque marker to aid in visualization under fluoroscopy. The inner diameter of the Houdini Catheter shaft will accommodate a standard commercially available 0.014" - 0.035" guidewire.
The balloon catheter is inflated to 6atm with radiopaque contrast media with a standard manual inflator to anchor the catheter. Internal forces are placed on the inner lumen to the point that it grips and stabilizes the guidewire. Once pressurized to 6 atm, the guidewire is advanced by manual control of the proximal Y-connector by the physician.
The Houdini Catheter requires the use of traditional manual inflation devices (not included).
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