510(k) Report

Devices descending from K760385

30 later devices reach Extension Sets through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031211Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular200329—
+2K082670Modification to: Attain Prevail 6228CTH80 Steerable Catheter SetMedtronic, Inc.20080—
+2K052575Luminary Cannulator Bideflectable Catheter with LumenSt Jude Medical20064—
+2K042194Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular200417—
+2K032622Attain Prevail Left Heart Delivery System Moddel, 6228SYSMedtronic Vascular20035—
+3K200721Agilis HisPro Steerable Catheter With ElectrodesAbbott (St. Jude Medical)20200—
+3K103083Agilis ES Steerable IntroducerSt Jude Medical20112—
+3K053431Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland200614—
+3K053217CPS Aim Inner Catheter, Models 410140, 410141, 410142, 410144, 410145, 410146, 410147…St Jude Medical200605
+3K053277CPS Direct SL Outer CatheterSt Jude Medical200601
+3K042381Coronary Sinus Visualization System, Model CSVS5508Acumen Medical, Inc.20043—
+4K171557AcQRef Introducer SheathAcutus Medical, Inc.20181—
+4K123153Attain Command+Surevalve Left Heart Delivery System Attain Command Guide Catheters for…Medtronic, Ireland20133—
+4K080428Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters…Medtronic, Inc.200813—
+4K070051Acumen Insight Endocardial Visualization SystemAcumen Medical, Inc.20070—
+4K050808Coronary Sinus Access Kit, Model KCS8F-01Cardio-Optics, Inc.20051—
+5K192712Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left…Medtronic, Inc.20201—
+5K192106AcQRef Introducer SheathAcutus Medical, Inc.20190—
+5K171819Attain Assist CS Access CatheterCreganna Medical Also Doing Business AS Ceganna Tactx Medica20180—
+5K090659Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left Heart…Medtronic, Inc.200912—
+5K062340Cardiooptics Augmentative Cardiac Optical Imaging SystemCardio-Optics, Inc.20060—
+6K222873Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery systemMedtronic20220—
+6K112917Attain LDS 6216A Left Heart Delivery System, Attain Access 6218A Left Heart Delivery…Medtronic, Inc.20110—
+6K101885Medtronic C315 Delivery CatheterMedtronic, Inc.201081
+7K190475Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery…Centerpoint Systems20195—
+8K250492FlexiGo 3D Delivery CatheterCenterPoint Systems, LLC20250—
+8K230363CPS Locator 3D Delivery CatheterCenterPoint Systems, LLC20233—
+9K250147CPS Locator 3D Delivery CatheterCenterpoint Systems20250—
+9K250828CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC20251—
+10K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC20260—