510(k) Report

Devices descending from K222217

5 later devices reach ViewFlex Xtra Reprocessed ICE Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230934ViewFlex™ Eco Reprocessed ICE CatheterAbbott Medical20234—
+2K231588ViewFlex™ Eco Reprocessed ICE CatheterAbbott Medical20233—
+3K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid…Abbott Medical20252—
+4K250305Reprocessed Agilis NxT Steerable IntroducerInnovative Health20260—
+4K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc.20250—