510(k) Report

Devices descending from K121196

8 later devices reach Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162625SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon CathetersB. Braun Interventional Systems, Inc.20170—
+1K163174Emerge PTCA Dilatation CatheterBoston Scientific Corporation201621
+1K130391Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca Dilatation Catheter…Boston Scientific Corp201371
+2K223022SC HONKYTONK PTCA Balloon Dilatation CatheterSino Medical Sciences Technology, Inc.20230—
+2K220629Emerge Monorail PTCA Dilatation CatheterBoston Scientific20220—
+2K173680Sapphire II PROOrbusneich Medical Trading, Inc.20181—
+2K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+3K233505Sapphire ULTRA Coronary Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20240—