510(k) Report

Devices descending from K133023

3 later devices reach Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172315Straub Endovascular SystemStraub Medical AG20182Class I
+2K211738Rotarex Atherectomy SystemC.R. Bard, Inc.20211Class I
+3K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.20250Class I