510(k) Report

Devices descending from K973298

60 later devices reach Cardima Vueport Coronary Sinus Balloon Occlusion Guiding Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042381Coronary Sinus Visualization System, Model CSVS5508Acumen Medical, Inc.20043—
+1K041151Kerberos Occluding Guide Catheter and AccessoriesKerberos Proximal Solutions, Inc.200425—
+1K021284Easytrak Guiding CatheterGuidant Corp.20022617
+1K021283Guidant Balloon Catheter, Several ModelsGuidant Corp.20020—
+1K012225Attain 6215 Venogram Balloon CatheterMedtronic Vascular20011—
+2K121219Attain Clarity 6225 Venogram Balloon CatheterMedtronic, Inc.20120—
+2K080987Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical2009241
+2K070051Acumen Insight Endocardial Visualization SystemAcumen Medical, Inc.20070—
+2K050808Coronary Sinus Access Kit, Model KCS8F-01Cardio-Optics, Inc.20051—
+2K021455Rapido Guiding Catheter, 6F Model# 6776; Rapido Guiding Catheter, 8F Model# 6775, 6777…Guidant Corp.20022518
+3K121763Multicross Support CatheterRoxwood Medical, Inc.20128—
+3K111963Bridgepoint Medical Mantaray (TM) CatheterBridgepoint Medical20117—
+3K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc.2011111
+3K101015Guide Catheters and AccessoriesThomas Medical Products, Inc.20100—
+3K101591Stingray Orienting Balloon CatheterBridgepoint Medical2010141
+3K062340Cardiooptics Augmentative Cardiac Optical Imaging SystemCardio-Optics, Inc.20060—
+3K053217CPS Aim Inner Catheter, Models 410140, 410141, 410142, 410144, 410145, 410146, 410147…St Jude Medical200605
+3K042194Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular200417—
+3K031505Rapido Cut-Away Guiding CatheterGuidant Corporation2003211
+4K193322NovaCross CTO MicrocatheterNitiloop, Ltd.20200—
+4K152957MultiCross CatheterRoxwood Medical, Inc.20160—
+4K152401Stingray LP CatheterBoston Scientific Corporation20151—
+4K143608NovaCross MicrocatheterNitiloop, Ltd.20152—
+4K140910Centercross CatheterRoxwood Medical, Inc.20143—
+4K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+4K122795Stingray GuidewiresBridgepoint Medical201201
+4K120533Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical20125—
+4K120129Mantaray CatheterBridgepoint Medical20126—
+4K093969Acuity Break-Away Guide CatheterCardiac Pacemakers, Inc.20104—
+4K053431Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland200614—
+4K053277CPS Direct SL Outer CatheterSt Jude Medical200601
+5K231176Stingray LP CatheterBoston Scientific20230—
+5K221163Tunnel Crossing CatheterTractus Vascular, LLC20230—
+5K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical20201—
+5K183357XableCath Crossing CatheterXablecath, Inc.20190—
+5K172297NovaCross MicrocatheterNitiloop, Ltd.20170—
+5K160389NovaCross MicrocatheterNitiloop, Ltd.20161—
+5K152456CenterCross Ultra CatheterRoxwood Medical, Inc.20162—
+5K132914Acuity Pro Lead Delivery SystemBoston Scientific201421
+5K123153Attain Command+Surevalve Left Heart Delivery System Attain Command Guide Catheters for…Medtronic, Ireland20133—
+5K121745Mantaray GuidewiresBridgepoint Medical20120—
+5K111252Acuity (TM) Cut-Away (TM) Guide Catheters 6F and 8FBoston Scientific Corp20113—
+5K080428Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters…Medtronic, Inc.200813—
+6K262013Kiba CTO Crossing CatheterReflow Medical, Inc.20260—
+6K192712Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left…Medtronic, Inc.20201—
+6K171819Attain Assist CS Access CatheterCreganna Medical Also Doing Business AS Ceganna Tactx Medica20180—
+6K171612ACUITY Pro Lead Delivery SystemBoston Scientific Corporation20171—
+6K160681CenterCross Ultra CatheterRoxwood Medical, Inc.20161—
+6K090659Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left Heart…Medtronic, Inc.200912—
+7K243757Shockwave CS Guide CatheterShockwave Medical, Inc.20250—
+7K222873Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery systemMedtronic20220—
+7K170403CenterCross Ultra LV CatheterRoxwood Medical, Inc.20170—
+7K112917Attain LDS 6216A Left Heart Delivery System, Attain Access 6218A Left Heart Delivery…Medtronic, Inc.20110—
+7K101885Medtronic C315 Delivery CatheterMedtronic, Inc.201081
+8K190475Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery…Centerpoint Systems20195—
+9K250492FlexiGo 3D Delivery CatheterCenterPoint Systems, LLC20250—
+9K230363CPS Locator 3D Delivery CatheterCenterPoint Systems, LLC20233—
+10K250147CPS Locator 3D Delivery CatheterCenterpoint Systems20250—
+10K250828CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC20251—
+11K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC20260—