510(k) Report

Devices descending from K974683

119 later devices reach Naviport Deflectable Tip Guiding Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K231176Stingray LP CatheterBoston Scientific20230—
+8K230363CPS Locator 3D Delivery CatheterCenterPoint Systems, LLC20233—
+8K221163Tunnel Crossing CatheterTractus Vascular, LLC20230—
+8K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical20201—
+8K183357XableCath Crossing CatheterXablecath, Inc.20190—
+8K172297NovaCross MicrocatheterNitiloop, Ltd.20170—
+8K160389NovaCross MicrocatheterNitiloop, Ltd.20161—
+8K152456CenterCross Ultra CatheterRoxwood Medical, Inc.20162—
+8K121745Mantaray GuidewiresBridgepoint Medical20120—
+9K262013Kiba CTO Crossing CatheterReflow Medical, Inc.20260—
+9K260942AuST Steerable SheathCenterPoint Systems, LLC20261—
+9K260163AuST CSP IntroducerCenterPoint Systems, LLC20260—
+9K250147CPS Locator 3D Delivery CatheterCenterpoint Systems20250—
+9K250828CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC20251—
+9K250426Amulet™ Steerable Delivery SheathAbbott Medical20250—
+9K160681CenterCross Ultra CatheterRoxwood Medical, Inc.20161—
+10K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC20260—
+10K261492FieldFlex Steerable SheathCenterPoint Systems, LLC20260—
+10K170403CenterCross Ultra LV CatheterRoxwood Medical, Inc.20170—