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510(k) Data Aggregation
K Number
K192399Device Name
Infinity Angioplasty Balloon Catheter
Manufacturer
Infinity Angioplasty Balloon Company, LLC
Date Cleared
2020-05-20
(260 days)
Product Code
LIT
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Infinity Angioplasty Balloon Company, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The INFINITY Angioplasty Balloon Catheter™ is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary or cerebrovascular arteries.
Device Description
The INFINITY Angioplasty Balloon Catheter is a intravascular angioplasty balloon catheter with a retractable sheath allowing a variable length inflatable balloon; up to 250mm. The over the wire (OTW) catheter has a retractable sheath allowing the balloon to be inflated at various lengths as determined by the physician. The balloon lengths are graduated with radiopaque marker bands denoting 0mm, 100mm, 200mm, and 250mm. The INFINITY Balloon Catheter is a 6Fr catheter system with a shaft working length of 150cm. The device uses a semi-compliant balloon with a rated burst pressure of 15atm and an indicated clinical use range of 4atm - 12atm. The balloon expands to a nominal diameter of 5.0 to 5.5mm.
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