510(k) Report

Devices descending from K030120

5 later devices reach Amsure Foley Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101824Amsure 3-Way Hydrophilic Latex Foley CatheterAmsino International, Inc.20100—
+1K091699Amsure Hydrophilic Latex Foley CatheterAmsino International, Inc.20094—
+2K162989Rusch Simplastic Foley CathetersTeleflexmedical, Inc.20172—
+3K212077Teleflex Rusch SoftSimplastic Foley CathetersTeleflexmedical, Inc.20231—
+4K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd.20260—