FDA 510(k) Applications for Medical Device Product Code "PCT"

FDA 510(k) Number Applicant Device Name Decision Date
K223249 DxTx Medical, Inc. Pro-Tx Endorectal Balloon (PROT-25) 02/10/2023
K141958 EDGE MEDICAL LLC ERB ENDORECTAL BALLOON 11/18/2014
K150234 Myriad Medical, LLC Myriad Prostate Caddy┐ Immobilization Rectal Balloon Item #9901,3301 03/31/2015
K180478 QLRAD International Ltd. RectalPro 75 Endorectal Balloon 11/13/2018
DEN130036 RADIADYNE PROSTATE IMMOBILIZER RECTAL BALLOON 01/28/2014


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