510(k) Report

Devices descending from K014117

8 later devices reach Modification to Outback Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032298Modification to Outback CatheterLumend, Inc.200372
+2K043534Modification to Outback CatheterLumend, Inc.200551
+2K040771Modification to Outback CatheterLumend, Inc.200461
+3K083814Outback LTD RE-Entry Catheter, Model: OTB42120Cordis Corp., A Johnson & Johnson Co.20094—
+4K150836OUTBACK Elite Re-Entry CatheterCordis Corporation, A Johnson & Johnson Co.20152—
+4K131914Offroad RE-Entry Catheter SystemBoston Scientific Corp20130—
+5K221541LimFlow ARCLimFlow, Inc.20221—
+6K251376LimFlow ARCLimFlow, Inc.20250—