510(k) Report

Devices descending from K130637

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181877Phoenix 2.4mm Atherectomy Plus SystemVolcano Atheromed, Inc.20180—
+1K133023Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6Medrad, Inc.201431
+2K172315Straub Endovascular SystemStraub Medical AG20182Class I
+3K211738Rotarex Atherectomy SystemC.R. Bard, Inc.20211Class I
+4K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.20250Class I