510(k) Report

Devices descending from K133853

14 later devices reach Viewflex Xtra Ice Catheter through their predicates, nearest generation first.

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