510(k) Report

Devices descending from K955651

120 later devices reach Medtronic Sherpa Guiding Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K232690Amulet™ Steerable Delivery SheathAbbott Medical20231—
+9K231176Stingray LP CatheterBoston Scientific20230—
+9K230363CPS Locator 3D Delivery CatheterCenterPoint Systems, LLC20233—
+9K221163Tunnel Crossing CatheterTractus Vascular, LLC20230—
+9K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical20201—
+9K183357XableCath Crossing CatheterXablecath, Inc.20190—
+9K172297NovaCross MicrocatheterNitiloop, Ltd.20170—
+9K160389NovaCross MicrocatheterNitiloop, Ltd.20161—
+9K152456CenterCross Ultra CatheterRoxwood Medical, Inc.20162—
+9K121745Mantaray GuidewiresBridgepoint Medical20120—
+10K262013Kiba CTO Crossing CatheterReflow Medical, Inc.20260—
+10K260942AuST Steerable SheathCenterPoint Systems, LLC20261—
+10K260163AuST CSP IntroducerCenterPoint Systems, LLC20260—
+10K250147CPS Locator 3D Delivery CatheterCenterpoint Systems20250—
+10K250828CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC20251—
+10K250426Amulet™ Steerable Delivery SheathAbbott Medical20250—
+10K160681CenterCross Ultra CatheterRoxwood Medical, Inc.20161—
+11K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC20260—
+11K261492FieldFlex Steerable SheathCenterPoint Systems, LLC20260—
+11K170403CenterCross Ultra LV CatheterRoxwood Medical, Inc.20170—