510(k) Report

Devices descending from K083814

4 later devices reach Outback LTD RE-Entry Catheter, Model: OTB42120 through their predicates, nearest generation first.

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