510(k) Report

Devices descending from K110626

10 later devices reach Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE System… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130637Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System…Medrad, Inc.20135—
+1K122916Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF…Medrad, Inc.20126—
+1K112308Crosser Recanalization SystemC.R. Bard, Inc.20112—
+2K181877Phoenix 2.4mm Atherectomy Plus SystemVolcano Atheromed, Inc.20180—
+2K161208CROSSER CTO Recanalization CatheterBard Peripheral Vacular, Inc.20161—
+2K133023Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6Medrad, Inc.201431
+3K203363Crosser iQ CTO Recanalization SystemC.R. Bard, Inc.202101
+3K172315Straub Endovascular SystemStraub Medical AG20182Class I
+4K211738Rotarex Atherectomy SystemC.R. Bard, Inc.20211Class I
+5K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.20250Class I