FDA 510(k) Applications Submitted by PENTAX Medical, A Division of PENTAX of America, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K190194 02/04/2019 C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge PENTAX Medical, A Division of PENTAX of America, Inc.
K193036 10/31/2019 C2 CryoBalloon EndoGrip PENTAX Medical, A Division of PENTAX of America, Inc.


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