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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K170635

Chameleon PTA Balloon Catheter · Av Medical Technologies, Ltd. · decided 2017-03-30 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
ChameleonCH09-40-75USMozarc Medical US LLCKRA LIT10884521812307
ChameleonCH10-40-75USMozarc Medical US LLCKRA LIT10884521812314