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510(k) Data Aggregation
K Number
K152665Device Name
PolarCath Peripheral Dilatation System
Manufacturer
Date Cleared
2015-10-26
(39 days)
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
NUCYRO VASCULAR, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PolarCath Peripheral Dilatation System's intended use is for the dilatation of stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or native arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.
Device Description
The PolarCath™ Peripheral Dilatation System (PolarCath System) consists of a disposable catheter, a reusable Cryoplasty inflation unit, a disposable nitrous oxide cartridge, and a disposable catheter extension.
The PolarCath System is designed for dilatation of stenotic lesions in peripheral arteries. The procedure consists of inserting a catheter over a quidewire to the target lesion, attaching the catheter to the catheter extension, attaching the catheter extension to the Inflation Unit, inserting a nitrous oxide cartridge into the Inflation Unit, and inflating the balloon catheter for a set time at a set pressure, using the controls on the Inflation Unit.
The Cryoplasty inflation unit functions to: a) deliver the inflation media (liquid nitrous oxide) to the balloon; b) control the pressure inside the inner balloon; c) provide a vacuum between the inner and outer balloons; and d) control the length of time for delivery of the inflation media which is manually extracted at the end of the inflation time. The inflation unit monitors the temperature inside the balloon. Excess pressure is prevented by the presence of a relief valve in the inflation unit.
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