510(k) Report

Devices descending from K960563

35 later devices reach Scimed Sceptor & Sceptor Exchange Ptca Guide Wires through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K974241Scimed Informer Pressure Wire SystemScimed Life Systems, Inc.19980—
+1K980385Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional…Datascope Corp.199817—
+1K980360Scimed Quest Floppy and Moderate Support Guide WiresScimed Life Systems, Inc.19980—
+1K965023Choice PT Plus Ptca Guide Wire and Choice PT Vision Ptca Guide WireScimed Life Systems, Inc.19972—
+1K962572Scimed Choice PT Vision Ptca Guide WireScimed Life Systems, Inc.1996163
+2K112745V-14 Control Wire GuidewireBoston Scientific Corporation20110—
+2K062582Supracor Balloon CatheterAbiomed, Inc.20061—
+2K030617PT2 Guide Wire and Addwire Extension WireBoston Scientific Scimed, Inc.2003114
+2K994157Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327…Datascope Corp.200015—
+3K180726Savion DLVR Guidewire, Savion FLX GuidewireBoston Scientific, Inc.20180—
+3K151840Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch…Boston Scientific Corporation20150—
+3K143587ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix…Boston Scientific Corporation201561
+3K082746Ultra Iabp Catheter Kit, Models IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20Insightra Medical, Inc.200901
+3K032183IQ Hydrophilic Guide WireBoston Scientific Corp20034—
+3K013326Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope…Datascope Corp.200114—
+4K170532True Form Reshapable Guide WireMerit Medical Systems, Inc.20170—
+4K152231Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 GuidewireBoston Scientific Corporation20162—
+4K091449Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models…Datascope Corp., Cardiac Assist Division20093—
+4K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…Datascope Corp.20078Class I
+4K041281Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp.2004117
+4K040140IQ Guide WireBoston Scientific Corp200431
+4K031569Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp.200312—
+4K020257Datascope's 8FR. Alt B Iab; Datascope's Profile 8FR. Alt B Iab; Datascope's True…Datascope Corp.20020—
+5K193194CrossTorq 14 GuidewireScientia Cardio Access, LLC20190—
+5K180795JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 GuidewireBoston Scientific20180—
+5K172305CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpDatascope Corp.201702
+5K133074Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon Catheters and AccessoriesDatascope Corp.201309
+5K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC20113Class I
+5K112327Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and AccessoriesCardiac Assist, Maquet Cardiovascular, LLC201121
+5K081021Kinetix Guidewire, Plus GuidewireBoston Scientific Corp20081—
+5K052783Modification to: IQ Guide Wire, Models 38950-XX. 38951-XXBoston Scientific Corp20050—
+6K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp.20180Class I
+6K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp.20151Class I
+6K122628Sensation Plus 7.5FR. 40CC Intra-Aortic Balloon (Iab) Catheter and AccessoriesDatascope Corp., Cardiac Assist Division201203
+7K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery…Datascope Corp.20170Class I