510(k) Report

Devices descending from K081187

13 later devices reach Bridgepoint Medical Entera Percutaneous Coronary and Peripheral Guidewire… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122795Stingray GuidewiresBridgepoint Medical201201
+1K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc.2011111
+1K083727Stingray Guidewire, Stiff, Models M-3003, M-3004, M-3011, M-3012Bridgepoint Medical200912—
+2K193322NovaCross CTO MicrocatheterNitiloop, Ltd.20200—
+2K152401Stingray LP CatheterBoston Scientific Corporation20151—
+2K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+2K120533Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical20125—
+3K231176Stingray LP CatheterBoston Scientific20230—
+3K221163Tunnel Crossing CatheterTractus Vascular, LLC20230—
+3K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical20201—
+3K183357XableCath Crossing CatheterXablecath, Inc.20190—
+3K121745Mantaray GuidewiresBridgepoint Medical20120—
+4K262013Kiba CTO Crossing CatheterReflow Medical, Inc.20260—