510(k) Report

Devices descending from K000011

13 later devices reach Modified Hydrophilic Coated Guidewire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133155Hydrophilic Coated GuidewireLake Region Medical20141—
+1K124052Ostavi Hydrophilic GuidewireLake Region Medical20130—
+1K092303Merit Laureate Hydrophilic Guide WireMerit Medical Systems, Inc.200996
+2K170915TXM Hydrophilic GuidewireTexasmedical Technologies, Inc.20170—
+2K120644Merit Hydrophilic Guide WireMerit Medical Systems, Inc.201282
+3K141295Merit Hydrophilic GuidewireMerit Medical Systems, Inc.20144—
+3K131710Merit Hydrophilic Guide WireMerit Medical Systems, Inc.20135—
+3K130588Merit Hydrophilic Guide WireMerit Medical Systems, Inc.20136—
+3K123609Merit Hydrophilic Guide WireMerit Medical Systems, Inc.20135—
+4K170933Merit Hydrophilic Guide WireMerit Medical Systems, Inc.20173—
+5K201595Merit Hydrophilic Guide WireMerit Medical Systems, Inc.202021
+6K251181Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire…Merit Medical Ireland, Ltd.20251—
+7K253847Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)Merit Medical Ireland, Ltd.20260—