510(k) Report

Devices descending from K073082

28 later devices reach CPS Courier Guidewire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120298CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi20128—
+1K103377Charter Guidewire Model 45-281, 45-282, 45-283Brivant, Ltd.20112—
+1K102211Cruiser 18 GuidewireBrivant, Ltd.20101—
+1K081187Bridgepoint Medical Entera Percutaneous Coronary and Peripheral Guidewire, Model M-3001Bridgepoint Medical200813—
+2K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc.20196Class I
+2K142254CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel…St Jude Medical20140—
+2K141831Hydraview GuidewireBrivant Limited20140—
+2K122795Stingray GuidewiresBridgepoint Medical201201
+2K122856Charter GuidewireBrivant, Ltd.20120—
+2K120137Victory Guidewire (32 Models)Brivant, Ltd.20120—
+2K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc.2011111
+2K083727Stingray Guidewire, Stiff, Models M-3003, M-3004, M-3011, M-3012Bridgepoint Medical200912—
+3K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc.20252Class I
+3K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…Centerline Biomedical, Inc.20243Class I
+3K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…Centerline Biomedical, Inc.20243Class I
+3K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc.20235Class I
+3K193322NovaCross CTO MicrocatheterNitiloop, Ltd.20200—
+3K152401Stingray LP CatheterBoston Scientific Corporation20151—
+3K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+3K120533Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical20125—
+4K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…Centerline Biomedical20260—
+4K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS…Centerline Biomedical, Inc.20260—
+4K231176Stingray LP CatheterBoston Scientific20230—
+4K221163Tunnel Crossing CatheterTractus Vascular, LLC20230—
+4K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical20201—
+4K183357XableCath Crossing CatheterXablecath, Inc.20190—
+4K121745Mantaray GuidewiresBridgepoint Medical20120—
+5K262013Kiba CTO Crossing CatheterReflow Medical, Inc.20260—