NFA · Class II · 21 CFR 870.1250

FDA Product Code NFA: Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection

Leading manufacturers include Boston Scientific Corp, Medtronic Vascular and Kensey Nash Corp..

22
Total
22
Cleared
139d
Avg days
2001
Since

FDA 510(k) Cleared Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection Devices (Product Code NFA)

22 devices
1–22 of 22
Cleared Aug 01, 2008
INTERCEPTOR PLUS CORONARY FILTER SYSTEMS
K073523
Medtronic, Inc.
Cardiovascular · 231d
Cleared Jan 31, 2008
MODIFICATION TO PROXIS SYSTEM
K073563
St Jude Medical
Cardiovascular · 43d
Cleared Jan 19, 2007
SPIDERFX EMBOLIC PROTECTION DEVICE
K063785
Ev3, Inc.
Cardiovascular · 29d
Cleared Oct 20, 2006
TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02
K062870
Kensey Nash Corp.
Cardiovascular · 25d
Cleared Sep 13, 2006
PROXIS SYSTEM, MODEL EPS101
K060651
St Jude Medical
Cardiovascular · 184d
Cleared Sep 07, 2006
PROXIS SYSTEM
K052523
Velocimed, Inc.
Cardiovascular · 358d
Cleared Aug 11, 2006
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM)
K061332
Boston Scientific Corp
Cardiovascular · 91d
Cleared Aug 11, 2006
SPIDERX EMBOLIC PROTECTION DEVICE
K062201
Ev3, Inc.
Cardiovascular · 10d
Cleared Jul 11, 2006
TRIACTIV FX EMBOLIC PROTECTION SYSTEM
K061772
Kensey Nash Corp.
Cardiovascular · 18d
Cleared Jun 23, 2006
SPIDERX EMBOLIC PROTECTION DEVICE
K053195
Ev3, Inc.
Cardiovascular · 220d
Cleared Apr 10, 2006
FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300
K051984
Boston Scientific Corp
Cardiovascular · 262d
Cleared Nov 07, 2005
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM
K052280
Boston Scientific Corp
Cardiovascular · 77d
Cleared Jun 08, 2005
EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150
K051179
Boston Scientific Corp
Cardiovascular · 30d
Cleared Mar 23, 2005
TRIACTIV SYSTEM
K042040
Kensey Nash Corp.
Cardiovascular · 237d
Cleared Mar 26, 2003
MODIFICATION TO EXPORT ASPIRATION CATHETER
K030201
Medtronic Vascular
Cardiovascular · 64d
Cleared Jan 24, 2003
GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
K023878
Medtronic Vascular
Cardiovascular · 64d
Cleared Oct 29, 2002
EXPORT ASPIRATION CATHETER
K023303
Medtronic Vascular
Cardiovascular · 26d

About Product Code NFA - Regulatory Context