510(k) Report

Devices descending from K111488

7 later devices reach Mantaray Guidewire Model M-6000, M-6001, M-6002, M-6003 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120533Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical20125—
+1K120881Mantaray GuidewiresBridgepoint Medical20121—
+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—