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510(k) K014223

Device
MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM
Applicant
MEDTRONIC PERCUSURGE, INC.
510(k) number
K014223
Product code
NFA  
Decision
Substantially Equivalent (SESE)
Decision date
2002-01-25
Date received
2001-12-26
Regulation
870.1250
Classification name
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MATT MOON
Address
540 Oakmead Pkwy. Sunnyvale CA US 94085 94085

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NFA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K073523INTERCEPTOR PLUS CORONARY FILTER SYSTEMSMedtronic, Inc.2008-08-01
K073563MODIFICATION TO PROXIS SYSTEMSt Jude Medical2008-01-31
K063785SPIDERFX EMBOLIC PROTECTION DEVICEEv3, Inc.2007-01-19
K062870TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03Kensey Nash Corp.2006-10-20
K060651PROXIS SYSTEM, MODEL EPS101St Jude Medical2006-09-13
K052523PROXIS SYSTEMVelocimed, Inc.2006-09-07
K062201SPIDERX EMBOLIC PROTECTION DEVICEEv3, Inc.2006-08-11
K061332FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM)Boston Scientific Corp2006-08-11
K061772TRIACTIV FX EMBOLIC PROTECTION SYSTEMKensey Nash Corp.2006-07-11
K053195SPIDERX EMBOLIC PROTECTION DEVICEEv3, Inc.2006-06-23
K051984FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300Boston Scientific Corp2006-04-10
K052280FILTERWIRE EZ EMBOLIC PROTECTION SYSTEMBoston Scientific Corp2005-11-07
K051179EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150Boston Scientific Corp2005-06-08
K042040TRIACTIV SYSTEMKensey Nash Corp.2005-03-23
K032884FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATHBoston Scientific Epi2004-08-06

Legacy Summary#

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FDA Review#

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