510(k) Report

Devices descending from K092378

4 later devices reach Spectranetics Visisheath Dilator Sheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133631Lexipliant Dilator Sheath SetSpectranetics Corporation20140—
+1K093554Retroflex Dilator KitEdwards Lifesciences, LLC20102—
+2K123842Lawmax DilatorLifetech Scientific (Shenzhen) Co., Ltd.20131—
+3K170616van Andel Dilatation CatheterCook Incorporated20170—