510(k) Report

Devices descending from K162989

2 later devices reach Rusch Simplastic Foley Catheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212077Teleflex Rusch SoftSimplastic Foley CathetersTeleflexmedical, Inc.20231—
+2K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd.20260—