510(k) Report

Devices descending from K955651

120 later devices reach Medtronic Sherpa Guiding Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K974683Naviport Deflectable Tip Guiding CatheterCardima, Inc.1999119—
+2K042553Biocardia Morph Universal Deflectable Guide CatheterBiocardia, Inc.20053—
+2K030630Edwards Directional CatheterEdwards Lifesciences, LLC20030—
+2K031211Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular200329—
+2K01351710600 Deflectable Catheter System, Model 10600Medtronic Vascular200280—
+2K012749Biocardia Universal Deflectable Guide Catheter, Model 000664Biocardia, Inc.200237—
+2K993445Omnisonic Endoscopic DeflectorOmnisonics Medical Technologies19990—
+3K192774BioCardia 8F Morph DNA Deflectable Guide CatheterBiocardia20201—
+3K090999Biocardia Morph Sheath GuideBiocardia, Inc.200903
+3K082670Modification to: Attain Prevail 6228CTH80 Steerable Catheter SetMedtronic, Inc.20080—
+3K052575Luminary Cannulator Bideflectable Catheter with LumenSt Jude Medical20064—
+3K043489Enpath Deflectable CatheterEnpath Medical Incorporated2005132
+3K042194Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular200417—
+3K040922Venture Wire Control CatheterVelocimed, Inc.200431Class I
+3K033989Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69Medtronic Inc. Cardiac Rhythm Management200435—
+3K032312Attain 6226DEF Deflectable Catheter Delivery SystemMedtronic Vascular200337—
+3K032622Attain Prevail Left Heart Delivery System Moddel, 6228SYSMedtronic Vascular20035—
+4K242169Morph DNA Steerable Introducer SheathBiocardia20240—
+4K200721Agilis HisPro Steerable Catheter With ElectrodesAbbott (St. Jude Medical)20200—
+4K183493SelectSite C304-HIS Deflectable Catheter SystemMedtronic, Inc.201901
+4K171335Venture 038 catheterVascular Solutions, Inc.20170—
+4K103083Agilis ES Steerable IntroducerSt Jude Medical20112—
+4K100135GDS-DC12Guided Delivery Systems20100—
+4K072313Amplatzer Torqvue Delivery SystemAga Medical Corp.2007301
+4K070238Amplatzer Reliant Catheter Delivery SystemAga Medical Corp.20070—
+4K061416Selectsite C304 Deflectable Catheter System, Models C304-S59, C304-L69, C304-XS59 &…Medtronic Vascular20061—
+4K061480Attain 6227DEF Deflectable Catheter Delivery SystemMedtronic, Ireland20060—
+4K061119Enpath Medical Steerable SheathEnpath Medical, Inc.200610—
+4K053431Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland200614—
+4K053217CPS Aim Inner Catheter, Models 410140, 410141, 410142, 410144, 410145, 410146, 410147…St Jude Medical200605
+4K053277CPS Direct SL Outer CatheterSt Jude Medical200601
+4K042381Coronary Sinus Visualization System, Model CSVS5508Acumen Medical, Inc.20043—
+4K042910Venture Wire Control Catheter, Model WCCVelocimed, Inc.200430Class I
+5K260993Amplatzer TorqVue Delivery SystemAbbott20260—
+5K202610Ventrax Delivery SystemMerit Medical Systems, Inc.20202—
+5K190581Amplatzer Trevisio Intravascular Delivery SystemAbbott Medical20192—
+5K182570Venture 0.014 CatheterVascular Solutions, LLC20192—
+5K171557AcQRef Introducer SheathAcutus Medical, Inc.20181—
+5K131063Amplatzer Torq Vue LP Delivery SystemSt Jude Medical201351
+5K123153Attain Command+Surevalve Left Heart Delivery System Attain Command Guide Catheters for…Medtronic, Ireland20133—
+5K122960Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc.20127—
+5K121611Amplatzer Torqvue FXAga Medical Corporation20120Class I
+5K100184Fustar Steerable IntroducersLifetech Scientific (Shenzhen) Co., Ltd.20110—
+5K101784Mobicath BI-Directional Guiding Sheath Model 1000182-XXXGreat Batch Medical201003
+5K093476Amplatzer Torq Vue 2 Delivery Sheath Model 9-TV2-05F120, Model 9-TV2-06F120…Aga Medical Corp.20100—
+5K091793Amplatzer Torqvue 3 Delivery Sheath, Model 9-TV3-08F104, 9-TV3-08F54Aga Medical Corp.20090—
+5K083214Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100…Aga Medical Corp.200910—
+5K080428Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters…Medtronic, Inc.200813—
+5K080994Amplatzer Torqvue Exchange SystemAga Medical Corp.20081—
+5K080757Amplatzer Torqvue Low Profile Delivery SystemAga Medical Corp.20087—
+5K070051Acumen Insight Endocardial Visualization SystemAcumen Medical, Inc.20070—
+5K061843Venture Wire Control Catheter, Model WCCSt Jude Medical200628Class I
+5K050808Coronary Sinus Access Kit, Model KCS8F-01Cardio-Optics, Inc.20051—
+6K261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott20260—
+6K261631Amplatzer TorqVue Exchange SystemAbbott Medical20260—
+6K260499Amplatzer™ Trevisio™ Intravascular Delivery System…Abbott Medical20260—
+6K241538TriClip Steerable Guide CatheterAbbott Medical20241—
+6K231246Ventrax™ Delivery System (VTR851)Merit Medical Systems, Inc.20231—
+6K223728Micro RxImds Operations B.V.20231—
+6K212738Amplatzer Talisman Delivery SheathAbbott Medical20210—
+6K192712Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left…Medtronic, Inc.20201—
+6K192106AcQRef Introducer SheathAcutus Medical, Inc.20190—
+6K180864WATCHMAN TruSeal Access SystemBoston Scientific20182Class I
+6K171819Attain Assist CS Access CatheterCreganna Medical Also Doing Business AS Ceganna Tactx Medica20180—
+6K163000AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO20164—
+6K162228TorqVue Low Profile Delivery CatheterAga Medical Corporation (Wholly Owned by St.Jude Medical Cor201621
+6K151951Destino ReachOscor, Inc.20156—
+6K120120Amplatzer Torqvue 45X45 Delivery Sheath Amplatzer Torqvue LA1 Delivery Sheath Amplatzer…Aga Medical Corporation20125—
+6K090659Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left Heart…Medtronic, Inc.200912—
+6K080987Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical2009241
+6K062340Cardiooptics Augmentative Cardiac Optical Imaging SystemCardio-Optics, Inc.20060—
+7K252417Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)Abbott Medical20250—
+7K242873Ventrax™ Delivery SystemMerit Medical Systems, Inc.20250—
+7K243224MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter…Abbott Medical20240—
+7K241611ShapeIT (SI014135)Imds Operations B.V.20240—
+7K240829AuST Steerable SheathCenterPoint Systems, LLC20245—
+7K222873Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery systemMedtronic20220—
+7K212026Amplatzer Steerable Delivery SheathAbbott Medical202131
+7K212228WATCHMAN FXD Curve Access SystemBoston Scientific Corporation20211Class I
+7K121763Multicross Support CatheterRoxwood Medical, Inc.20128—
+7K112917Attain LDS 6216A Left Heart Delivery System, Attain Access 6218A Left Heart Delivery…Medtronic, Inc.20110—
+7K111963Bridgepoint Medical Mantaray (TM) CatheterBridgepoint Medical20117—
+7K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc.2011111
+7K101885Medtronic C315 Delivery CatheterMedtronic, Inc.201081
+7K101591Stingray Orienting Balloon CatheterBridgepoint Medical2010141
+8K242106AuST Steerable SheathCenterPoint Systems, LLC20244—
+8K240018WATCHMAN TruSteer Access System (M635TU90050)Boston Scientific Corporation20240Class I
+8K220340Amplatzer Steerable Delivery SheathAbbott Medical20222Class I
+8K193322NovaCross CTO MicrocatheterNitiloop, Ltd.20200—
+8K190475Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery…Centerpoint Systems20195—
+8K152957MultiCross CatheterRoxwood Medical, Inc.20160—
+8K152401Stingray LP CatheterBoston Scientific Corporation20151—
+8K143608NovaCross MicrocatheterNitiloop, Ltd.20152—
+8K140910Centercross CatheterRoxwood Medical, Inc.20143—
+8K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+8K122795Stingray GuidewiresBridgepoint Medical201201
+8K120533Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical20125—
+8K120129Mantaray CatheterBridgepoint Medical20126—
+9K250492FlexiGo 3D Delivery CatheterCenterPoint Systems, LLC20250—
+9K251051AuST Steerable SheathCenterPoint Systems, LLC20253—