510(k) Report

Devices descending from K101239

16 later devices reach Viewflex Plus Ice Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121381Viewflex Xtra Ice CatheterSt Jude Medical201215—
+2K133853Viewflex Xtra Ice CatheterIrvine Biomedical, Inc., A St. Jude Medical Company201414—
+3K232130Medline ReNewal Reprocessed ViewFlex Xtra ICE CatheterSurgical Instrument Services and Savings, Inc.20230Class I
+3K231621Reprocessed ViewFlex Xtra ICE Catheter (D087031)Stryker Sustainability Solutions20230—
+3K222217ViewFlex Xtra Reprocessed ICE CatheterAbbott Medical20225—
+3K223077ViewFlex Xtra ICE CatheterIrvine Biomedical, A St. Jude Medical Company20224—
+3K202042Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound CatheterInnovative Health, LLC20200—
+3K190478Reprocessed ViewFlex™ Xtra ICE CatheterSterilmed, Inc.20190—
+3K182238Reprocessed ViewFlex Xtra ICE CatheterStryker Sustainability Solutions201911
+3K173262Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound CatheterInnovative Health, LLC20181—
+4K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid…Abbott Medical20252—
+4K251231ViewFlex™ X ICE Catheter, Sensor Enabled™Abbott Medical20250—
+4K230934ViewFlex™ Eco Reprocessed ICE CatheterAbbott Medical20234—
+5K250305Reprocessed Agilis NxT Steerable IntroducerInnovative Health20260—
+5K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc.20250—
+5K231588ViewFlex™ Eco Reprocessed ICE CatheterAbbott Medical20233—