510(k) Report

Devices descending from K001577

23 later devices reach Outback Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182937Upstream GoBack Crossing CatheterUpstream Peripheral Technologies, Ltd.20191—
+1K101479Wingman Extendable Tip Support CatheterReflow Medical20105—
+1K032298Modification to Outback CatheterLumend, Inc.200372
+1K013363Crosspoint Transaccess CatheterTrans Vascular Incorporated20025—
+1K014117Modification to Outback CatheterLumend, Inc.200281
+2K211802GoBack Crossing CatheterUpstream Peripheral Technologies, Ltd.20220—
+2K120178Wingman Extendable Tip Support CatheterReflow Medical20124—
+2K072155Pioneer CatheterMedtronic, Inc.20073—
+2K043534Modification to Outback CatheterLumend, Inc.200551
+2K040771Modification to Outback CatheterLumend, Inc.200461
+2K031920Crosspoint Transaccess Catheter, Model TA-XP-001Trans Vascular Incorporated200341
+3K132420Wingman Extendable Tip Support CatheterReflow Medical20133—
+3K083814Outback LTD RE-Entry Catheter, Model: OTB42120Cordis Corp., A Johnson & Johnson Co.20094—
+3K081804Pioneer Plus CatheterMedtronic, Inc.200822
+4K151880Wingman Crossing CatheterReflow Medical20150—
+4K150836OUTBACK Elite Re-Entry CatheterCordis Corporation, A Johnson & Johnson Co.20152—
+4K141547Wingman Extendable Tip Support CatheterReflow Medical20142Class I
+4K131914Offroad RE-Entry Catheter SystemBoston Scientific Corp20130—
+4K101777Pioneer Plus Catheter, Model Plus 120Medtronic Vascular201011
+5K221541LimFlow ARCLimFlow, Inc.20221—
+5K173661Wingman 35 Crossing CatheterReflow Medical, Inc.20180—
+5K162418Pioneer Plus CatheterPhilips Volcano20160—
+6K251376LimFlow ARCLimFlow, Inc.20250—