510(k) Report

Devices descending from K043534

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

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