510(k) Report

Devices descending from K111963

7 later devices reach Bridgepoint Medical Mantaray (TM) Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120533Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical20125—
+1K120129Mantaray CatheterBridgepoint Medical20126—
+2K221163Tunnel Crossing CatheterTractus Vascular, LLC20230—
+2K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical20201—
+2K183357XableCath Crossing CatheterXablecath, Inc.20190—
+2K121745Mantaray GuidewiresBridgepoint Medical20120—
+3K262013Kiba CTO Crossing CatheterReflow Medical, Inc.20260—