FDA 510(k) Applications for Medical Device Product Code "KOE"
(Dilator, Urethral)

FDA 510(k) Number Applicant Device Name Decision Date
K972964 ATRION MEDICAL PRODUCTS, INC. ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE 10/10/1997
K032840 ATRION MEDICAL PRODUCTS, INC. ATRION MEDICAL QL INFLATION DEVICE 03/03/2004
K961904 COOK UROLOGICAL, INC. AQ HYDROPHILIC DILATORS 10/18/1996
K962611 RYDER INTL. CORP. BARD EAGLE INFLATION DEVICE 10/21/1996
K191061 Urotronic Inc Optilume Basic Urological Balloon Dilation Catheter 01/02/2020


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