510(k) Report

Devices descending from K031211

29 later devices reach Attain Prevail Steerable Catheter Set, Model 6228CTH through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082670Modification to: Attain Prevail 6228CTH80 Steerable Catheter SetMedtronic, Inc.20080—
+1K052575Luminary Cannulator Bideflectable Catheter with LumenSt Jude Medical20064—
+1K042194Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular200417—
+1K032622Attain Prevail Left Heart Delivery System Moddel, 6228SYSMedtronic Vascular20035—
+2K200721Agilis HisPro Steerable Catheter With ElectrodesAbbott (St. Jude Medical)20200—
+2K103083Agilis ES Steerable IntroducerSt Jude Medical20112—
+2K053431Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland200614—
+2K053217CPS Aim Inner Catheter, Models 410140, 410141, 410142, 410144, 410145, 410146, 410147…St Jude Medical200605
+2K053277CPS Direct SL Outer CatheterSt Jude Medical200601
+2K042381Coronary Sinus Visualization System, Model CSVS5508Acumen Medical, Inc.20043—
+3K171557AcQRef Introducer SheathAcutus Medical, Inc.20181—
+3K123153Attain Command+Surevalve Left Heart Delivery System Attain Command Guide Catheters for…Medtronic, Ireland20133—
+3K080428Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters…Medtronic, Inc.200813—
+3K070051Acumen Insight Endocardial Visualization SystemAcumen Medical, Inc.20070—
+3K050808Coronary Sinus Access Kit, Model KCS8F-01Cardio-Optics, Inc.20051—
+4K192712Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left…Medtronic, Inc.20201—
+4K192106AcQRef Introducer SheathAcutus Medical, Inc.20190—
+4K171819Attain Assist CS Access CatheterCreganna Medical Also Doing Business AS Ceganna Tactx Medica20180—
+4K090659Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left Heart…Medtronic, Inc.200912—
+4K062340Cardiooptics Augmentative Cardiac Optical Imaging SystemCardio-Optics, Inc.20060—
+5K222873Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery systemMedtronic20220—
+5K112917Attain LDS 6216A Left Heart Delivery System, Attain Access 6218A Left Heart Delivery…Medtronic, Inc.20110—
+5K101885Medtronic C315 Delivery CatheterMedtronic, Inc.201081
+6K190475Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery…Centerpoint Systems20195—
+7K250492FlexiGo 3D Delivery CatheterCenterPoint Systems, LLC20250—
+7K230363CPS Locator 3D Delivery CatheterCenterPoint Systems, LLC20233—
+8K250147CPS Locator 3D Delivery CatheterCenterpoint Systems20250—
+8K250828CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC20251—
+9K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC20260—