510(k) Report

Devices descending from K000659

18 later devices reach Modification to Softouch Diagnostic Intravascular Cat through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143604Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic…Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S20150—
+1K101625Cohen Crossover CatheterVascular Solutions, Inc.20100—
+1K091367GDS-DCSGuided Delivery Systems20091—
+1K062627Innerchange Micro-Introducer Catheter, Models 7900 Through 7905Vascular Solutions, Inc.20072—
+1K053171Merit Impress Diagnostic CatheterMerit Medical Systems, Inc.200610—
+2K233268Impress Angiographic CatheterMerit Medical Systems, Inc.20240—
+2K130378Respiguide Delivery SystemRespicardia20130—
+2K120158Coronary Sinus Guide and Lateral Vein Introducer KitsThomas Medical Products, Inc.201232
+2K101015Guide Catheters and AccessoriesThomas Medical Products, Inc.20100—
+2K100135GDS-DC12Guided Delivery Systems20100—
+2K093004Impress Angiographic Catheter with Hydrophilic CoatingMerit Medical Systems, Inc.20104—
+2K073585Innerchange Micro-Introducer Catheter, Models 7900, 7901, 7902, 7903, 7904 and 7905Vascular Solutions, Inc.20081—
+3K191608Impress Angiographic CatheterMerit Medical Systems, Inc.20192—
+3K1521165.5 F Worley Advanced LVI Lateral Vein IntroducerMerit Medical Systems, Inc.20151—
+3K133501Leadliner CS Lead Delivery SystemVascular Solutions, Inc.20140—
+3K081846Grebset Micro-Introducer Kit, Models 7950, 7951Vascular Solutions, Inc.200901
+4K260459VANES Delivery System (VDS)Zoll Respicardia, Inc.20260—
+4K233975Zoom 6F Insert CathetersImperative Care, Inc.20240—