Product Code: NFA FDA class 2 21 CFR 870.1250

Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection

Cardiovascular

The Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection (product code NFA) is a cardiovascular device that uses a temporary bypass conduit constructed from saphenous vein to protect against distal embolization during percutaneous coronary interventions or cardiac surgery. It is classified as an FDA Class 2 device within the Cardiovascular specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as a permanent implant or life-sustaining device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: NFA
Device Class: FDA class 2
Regulation Number: 870.1250
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 22 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K073523	INTERCEPTOR PLUS CORONARY FILTER SYSTEMS	Aug 01, 2008	Substantially Equivalent	Medtronic, Inc.
K073563	MODIFICATION TO PROXIS SYSTEM	Jan 31, 2008	Substantially Equivalent	St Jude Medical
K063785	SPIDERFX EMBOLIC PROTECTION DEVICE	Jan 19, 2007	Substantially Equivalent	Ev3, Inc.
K062870	TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03	Oct 20, 2006	Substantially Equivalent	Kensey Nash Corp.
K060651	PROXIS SYSTEM, MODEL EPS101	Sep 13, 2006	Substantially Equivalent	St Jude Medical
K052523	PROXIS SYSTEM	Sep 07, 2006	Substantially Equivalent	Velocimed, Inc.
K062201	SPIDERX EMBOLIC PROTECTION DEVICE	Aug 11, 2006	Substantially Equivalent	Ev3, Inc.
K061332	FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM)	Aug 11, 2006	Substantially Equivalent	Boston Scientific Corp
K061772	TRIACTIV FX EMBOLIC PROTECTION SYSTEM	Jul 11, 2006	Substantially Equivalent	Kensey Nash Corp.
K053195	SPIDERX EMBOLIC PROTECTION DEVICE	Jun 23, 2006	Substantially Equivalent	Ev3, Inc.
K051984	FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300	Apr 10, 2006	Substantially Equivalent	Boston Scientific Corp
K052280	FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM	Nov 07, 2005	Substantially Equivalent	Boston Scientific Corp
K051179	EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150	Jun 08, 2005	Substantially Equivalent	Boston Scientific Corp
K042040	TRIACTIV SYSTEM	Mar 23, 2005	Substantially Equivalent	Kensey Nash Corp.
K032884	FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH	Aug 06, 2004	Substantially Equivalent	Boston Scientific Epi
K023691	BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC	Jun 04, 2003	Substantially Equivalent	Boston Scientific Epi
K030201	MODIFICATION TO EXPORT ASPIRATION CATHETER	Mar 26, 2003	Substantially Equivalent	Medtronic Vascular
K023878	GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM	Jan 24, 2003	Substantially Equivalent	Medtronic Vascular
K013913	PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM	Nov 15, 2002	Substantially Equivalent	Medtronic Percusurge, Inc.
K023303	EXPORT ASPIRATION CATHETER	Oct 29, 2002	Substantially Equivalent	Medtronic Vascular
K014223	MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM	Jan 25, 2002	Substantially Equivalent	Medtronic Percusurge, Inc.
K003992	PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM	Jun 01, 2001	Substantially Equivalent	Percu Surge, Inc.