510(k) Report

Devices descending from K111417

4 later devices reach The Powerwand (R) Safety Introducer with an Extended Dwell Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131300The Powerwand Safety Introducer with an Extended Dwell CatheterAccess Scientific, LLC201321
+1K121748The Powerwand Safety Introducer with and Extended DwellAccess Scientific, Inc.201231
+2K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. ModelAccess Scientific, LLC20161—
+3K183066The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C®…Access Scientific, LLC20190—