510(k) Report

Devices descending from K040771

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

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