510(k) Report

Devices descending from K931794

130 later devices reach Marinr Series EP Diagnostic Catheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K251051AuST Steerable SheathCenterPoint Systems, LLC20253—
+8K232690Amulet™ Steerable Delivery SheathAbbott Medical20231—
+8K230363CPS Locator 3D Delivery CatheterCenterPoint Systems, LLC20233—
+8K193322NovaCross CTO MicrocatheterNitiloop, Ltd.20200—
+8K152957MultiCross CatheterRoxwood Medical, Inc.20160—
+8K152401Stingray LP CatheterBoston Scientific Corporation20151—
+8K143608NovaCross MicrocatheterNitiloop, Ltd.20152—
+8K140910Centercross CatheterRoxwood Medical, Inc.20143—
+8K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+8K122795Stingray GuidewiresBridgepoint Medical201201
+8K120533Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical20125—
+8K120129Mantaray CatheterBridgepoint Medical20126—
+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—
+9K231176Stingray LP CatheterBoston Scientific20230—
+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—
+10K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC20260—
+10K261492FieldFlex Steerable SheathCenterPoint Systems, LLC20260—
+10K160681CenterCross Ultra CatheterRoxwood Medical, Inc.20161—
+11K170403CenterCross Ultra LV CatheterRoxwood Medical, Inc.20170—