510(k) Report

Devices descending from K963320

103 later devices reach TFX Medical Guidewire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K260163AuST CSP IntroducerCenterPoint Systems, LLC20260—
+10K250426Amulet™ Steerable Delivery SheathAbbott Medical20250—
+11K261492FieldFlex Steerable SheathCenterPoint Systems, LLC20260—