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NFA — Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection Class II

FDA Device Classification

Classification Details

Product Code
NFA
Device Class
Class II
Regulation Number
870.1250
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K073523medtronicINTERCEPTOR PLUS CORONARY FILTER SYSTEMSAugust 1, 2008
K073563st jude medicalMODIFICATION TO PROXIS SYSTEMJanuary 31, 2008
K063785ev3SPIDERFX EMBOLIC PROTECTION DEVICEJanuary 19, 2007
K062870kensey nashTRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03October 20, 2006
K060651st jude medicalPROXIS SYSTEM, MODEL EPS101September 13, 2006
K052523velocimedPROXIS SYSTEMSeptember 7, 2006
K061332boston scientificFILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM)August 11, 2006
K062201ev3SPIDERX EMBOLIC PROTECTION DEVICEAugust 11, 2006
K061772kensey nashTRIACTIV FX EMBOLIC PROTECTION SYSTEMJuly 11, 2006
K053195ev3SPIDERX EMBOLIC PROTECTION DEVICEJune 23, 2006
K051984boston scientificFILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20April 10, 2006
K052280boston scientificFILTERWIRE EZ EMBOLIC PROTECTION SYSTEMNovember 7, 2005
K051179boston scientificEZ PLUS RETRIEVAL SHEATH, MODEL 38899-150June 8, 2005
K042040kensey nashTRIACTIV SYSTEMMarch 23, 2005
K032884boston scientific epiFILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATHAugust 6, 2004
K023691boston scientific epiBOSTON SCIENTIFIC FILTERWIRE EX EMBOLICJune 4, 2003
K030201medtronic vascularMODIFICATION TO EXPORT ASPIRATION CATHETERMarch 26, 2003
K023878medtronic vascularGUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEMJanuary 24, 2003
K013913medtronic percusurgePERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEMNovember 15, 2002
K023303medtronic vascularEXPORT ASPIRATION CATHETEROctober 29, 2002