510(k) Report

Devices descending from K021284

26 later devices reach Easytrak Guiding Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021455Rapido Guiding Catheter, 6F Model# 6776; Rapido Guiding Catheter, 8F Model# 6775, 6777…Guidant Corp.20022518
+2K101015Guide Catheters and AccessoriesThomas Medical Products, Inc.20100—
+2K053217CPS Aim Inner Catheter, Models 410140, 410141, 410142, 410144, 410145, 410146, 410147…St Jude Medical200605
+2K042194Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular200417—
+2K031505Rapido Cut-Away Guiding CatheterGuidant Corporation2003211
+3K093969Acuity Break-Away Guide CatheterCardiac Pacemakers, Inc.20104—
+3K053431Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland200614—
+3K053277CPS Direct SL Outer CatheterSt Jude Medical200601
+4K132914Acuity Pro Lead Delivery SystemBoston Scientific201421
+4K123153Attain Command+Surevalve Left Heart Delivery System Attain Command Guide Catheters for…Medtronic, Ireland20133—
+4K111252Acuity (TM) Cut-Away (TM) Guide Catheters 6F and 8FBoston Scientific Corp20113—
+4K080428Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters…Medtronic, Inc.200813—
+5K192712Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left…Medtronic, Inc.20201—
+5K171819Attain Assist CS Access CatheterCreganna Medical Also Doing Business AS Ceganna Tactx Medica20180—
+5K171612ACUITY Pro Lead Delivery SystemBoston Scientific Corporation20171—
+5K090659Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left Heart…Medtronic, Inc.200912—
+6K243757Shockwave CS Guide CatheterShockwave Medical, Inc.20250—
+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—