The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, non-compliant balloon systems mounted at the distal tip (balloon within a balloon design). The catheter is available in various working lengths and appropriate balloon diameters and lengths. The balloon has radiopaque markings to assist in balloon placement and to visualize proper expansion of the inflated balloon. The catheter tip is tapered to facilitate entry into peripheral arteries and across lesions. The catheter is designed to be used with appropriately sized guidewires and introducers.
Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels.
U.S.: CA, TX, OK, AR, MI, MS. No foreign (OUS) distribution
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0507-2020