510(k) Report

Devices descending from K061063

37 later devices reach Modification to: Silverhawk Peripheral Plaque Excision System, Models… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170191SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision SystemMedtronic Vascular, Inc.20171—
+1K132682Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking Atherectomy Catheter…Atheromed, Inc.20146—
+1K081328Pathway PV Atherectomy SystemPathway Medical Technologies, Inc.200834—
+2K212027TurboHawk Plus Directional Atherectomy SystemMedtronic, Inc.20210Class I
+2K1511452.4mm X 127 cm Phoenix Atherectomy Deflecting SystemVolcano Atheromed, Inc.20152—
+2K1409441.8 MM Phoenix Atherectomy Catheter, 2.2 MM Phoenix Atherectomy Catheter, Phoenix…Atheromed, Inc.20145—
+2K130637Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System…Medrad, Inc.20135—
+2K122916Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF…Medrad, Inc.20126—
+2K120242Jetstream Navitus L SystemPathway Medical Technologies, Inc.201214—
+2K111229Jetstream G3 (R) SF 1.6 SystemPathway Medical Technologies, Inc.201115—
+2K110626Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE System; Jetstream G3 L…Pathway Medical Technologies, Inc.201110—
+2K101334Jetstream G3 SE System, Jetstream G3 SF System Model PV31230 (Jetstream G3 SE Catheter…Pathway Medical Technologies, Inc.201020—
+2K101221Jetstream G3 System, Model PV31300, PV Console, Model PVCN100Pathway Medical Technologies, Inc.201019—
+2K100462Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100Pathway Medical Technologies, Inc.201022—
+2K093918Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with Control Pod); PVCN100…Pathway Medical Technologies, Inc.201023—
+2K092332Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod)., PVCN100…Pathway Medical Technologies, Inc.200925—
+2K091509Jetstream G2 NXT System, Model PV20300Pathway Medical Technologies, Inc.200926—
+2K083489Jetstream Pathway PC Atherectomy System, Model OV10300Pathway Medical Technologies, Inc.200928—
+2K082664Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100Pathway Medical Technologies, Inc.200832—
+2K082186Modification to Pathway PV Atherectomy SystemPathway Medical Technologies, Inc.200833—
+3K191419Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy GuidewireRex Medical, L.P.20191—
+3K182972Phoenix Atherectomy SystemVolcano Atheromed, Inc.20181—
+3K181877Phoenix 2.4mm Atherectomy Plus SystemVolcano Atheromed, Inc.20180—
+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—
+3K133023Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6Medrad, Inc.201431
+3K112308Crosser Recanalization SystemC.R. Bard, Inc.20112—
+3K093456Jetstream G3 SystemPathway Medical Technologies, Inc.200924—
+3K090325Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV…Pathway Medical Technologies, Inc.200927—
+3K083837Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV…Pathway Medical Technologies, Inc.200928—
+4K212351Revolution Peripheral Atherectomy SystemRex Medical, L.P.20210—
+4K2115182.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy…Volcano Atheromed, Inc.20210—
+4K172315Straub Endovascular SystemStraub Medical AG20182Class I
+4K161208CROSSER CTO Recanalization CatheterBard Peripheral Vacular, Inc.20161—
+5K211738Rotarex Atherectomy SystemC.R. Bard, Inc.20211Class I
+5K203363Crosser iQ CTO Recanalization SystemC.R. Bard, Inc.202101
+6K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.20250Class I