510(k) Report

Devices descending from K193012

2 later devices reach speX Support Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201811coraForce and coraFlex Support CathetersReflow Medical, Inc.20201—
+2K251277CoraForce Microcatheter, CoraFlex MicrocatheterReflow Medical, Inc.20250—