510(k) Report

Devices descending from K241370

4 later devices reach Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243493Agilis NxT Steerable Introducer Dual-ReachAbbott Medical20243—
+2K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid…Abbott Medical20252—
+3K250305Reprocessed Agilis NxT Steerable IntroducerInnovative Health20260—
+3K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc.20250—