510(k) Report

Devices descending from K111229

15 later devices reach Jetstream G3 (R) SF 1.6 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132682Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking Atherectomy Catheter…Atheromed, Inc.20146—
+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—
+1K120242Jetstream Navitus L SystemPathway Medical Technologies, Inc.201214—
+2K181877Phoenix 2.4mm Atherectomy Plus SystemVolcano Atheromed, Inc.20180—
+2K1511452.4mm X 127 cm Phoenix Atherectomy Deflecting SystemVolcano Atheromed, Inc.20152—
+2K133023Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6Medrad, Inc.201431
+2K1409441.8 MM Phoenix Atherectomy Catheter, 2.2 MM Phoenix Atherectomy Catheter, Phoenix…Atheromed, Inc.20145—
+3K182972Phoenix Atherectomy SystemVolcano Atheromed, Inc.20181—
+3K172315Straub Endovascular SystemStraub Medical AG20182Class I
+3K1723861.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System…Volcano Atheromed, Inc.20172—
+3K1433281.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy…Volcano Atheromed, Inc.20143—
+4K211738Rotarex Atherectomy SystemC.R. Bard, Inc.20211Class I
+4K2115182.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy…Volcano Atheromed, Inc.20210—
+5K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.20250Class I