510(k) Report

Devices descending from K023337

16 later devices reach Cre Pulmonary Balloon Dilatation Catheter, Models K00550300, M00550310… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170759CRE Pulmonary Balloon Dilatation CatheterBoston Scientific Corporation20172—
+1K161392Elation Pulmonary Balloon DilationMerit Medical Systems, Inc.20161—
+1K150951aeris Balloon Dialation CatheterBryan Medical, Inc.201511
+1K131234Lungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon)Broncus Medical, Inc.20135—
+1K110218Inspira Air Balloon Dilation SystemAcclarent, Inc.201109
+1K090660Airway Balloon Catheter Inflation DeviceAcclarent, Inc.200947
+2K232601BroncTru™ Transbronchial Access ToolBroncus Medical, Inc.20240—
+2K231818METIC™- Airway Balloon CatheterM/S Meril Life Sciences Pvt., Ltd.20230—
+2K222187Multistage Balloon Dilatation CatheterDongguan TT Medical, Inc.20230—
+2K213434Elation Pulmonary Balloon Dilation CatheterMerit Medical Systems, Inc.20220—
+2K211894TrachealatorDisa Medinotec20210—
+2K200702EasyPath RF Introducer SheathBroncus Medical, Inc.20210—
+2K153484Dillard Airway Dilatation SystemIntuit Medical Products, LLC20160—
+2K142934CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access…Covidien20152—
+2K150280PulmoVia Working ChannelSanovas, Inc.20150—
+3K260565SmartClip Delivery Catheter (ADR-1715)Elucent Medical20260—