Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797

Reason: Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications

Code information: All Lots containing IFU Part Number 300004856772/A Revision Date: 05/2021 , ; UDI/DI: 00845225002329

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of NY, CA, AZ, LA, NV, AL, MI, WI, CO, TX, NJ, OR, FL, KS, IL, MD, PA, OH, NC, OK, MN, AK, GA, MO, SC, MS, KY, AR, VA, SD, TN, MA, DE, NE, MT, CT, WV, WA, IN, IA, HI, NH, WY, UT, ID, DC, RI, NM, ME, VT and the countries of ES, SE, FR, PR, IT, DE, CA, NZ, PL, BR, ZA, NL.