510(k) Report

Devices descending from K121748

3 later devices reach The Powerwand Safety Introducer with and Extended Dwell through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131300The Powerwand Safety Introducer with an Extended Dwell CatheterAccess Scientific, LLC201321
+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—