510(k) Report

Devices descending from K171999

5 later devices reach Performer Introducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242520Element Vascular Access SystemPenumbra, Inc.20240—
+1K231828Pounce™ SheathSurmodics,Inc.20231—
+1K230631Kodiak™ Dual Port Coaxial Introducer KitArgon Medical Devices20230—
+1K173068Performer IntroducerCook Incorporated20170—
+2K252227Pounce (TM) SheathSurmodics,Inc.20250—