Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1250](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1250) → NFA — Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection # NFA · Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection _Cardiovascular · 21 CFR 870.1250 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NFA ## Overview - **Product Code:** NFA - **Device Name:** Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection - **Regulation:** [21 CFR 870.1250](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1250) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) ## Identification A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 22) Showing 20 most recent of 22 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K073523](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NFA/K073523.md) | INTERCEPTOR PLUS CORONARY FILTER SYSTEMS | Medtronic, Inc. | Aug 1, 2008 | SESE | | [K073563](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NFA/K073563.md) | MODIFICATION TO PROXIS SYSTEM | St Jude Medical | Jan 31, 2008 | SESE | | [K063785](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NFA/K063785.md) | SPIDERFX EMBOLIC PROTECTION DEVICE | Ev3, Inc. | Jan 19, 2007 | SESE | | [K062870](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NFA/K062870.md) | TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 | Kensey Nash Corp. | Oct 20, 2006 | SESE | | [K060651](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NFA/K060651.md) | PROXIS SYSTEM, MODEL EPS101 | St Jude Medical | Sep 13, 2006 | SESE | | [K052523](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NFA/K052523.md) | PROXIS SYSTEM | Velocimed, Inc. | Sep 7, 2006 | SESE | | [K062201](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NFA/K062201.md) | SPIDERX EMBOLIC PROTECTION DEVICE | Ev3, Inc. | Aug 11, 2006 | SESE | | [K061332](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NFA/K061332.md) | FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM) | Boston Scientific Corp | Aug 11, 2006 | SESE | | [K061772](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NFA/K061772.md) | TRIACTIV FX EMBOLIC PROTECTION SYSTEM | Kensey Nash Corp. | Jul 11, 2006 | SESE | | [K053195](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NFA/K053195.md) | SPIDERX EMBOLIC PROTECTION DEVICE | Ev3, Inc. | Jun 23, 2006 | SESE | | [K051984](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NFA/K051984.md) | FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300 | Boston Scientific Corp | Apr 10, 2006 | SESE | | [K052280](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NFA/K052280.md) | FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM | Boston Scientific Corp | Nov 7, 2005 | SESE | | [K051179](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NFA/K051179.md) | EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150 | Boston Scientific Corp | Jun 8, 2005 | SESE | | [K042040](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NFA/K042040.md) | TRIACTIV SYSTEM | Kensey Nash Corp. | Mar 23, 2005 | SESE | | [K032884](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NFA/K032884.md) | FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH | Boston Scientific Epi | Aug 6, 2004 | SESE | | [K023691](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NFA/K023691.md) | BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC | Boston Scientific Epi | Jun 4, 2003 | SESE | | [K030201](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NFA/K030201.md) | MODIFICATION TO EXPORT ASPIRATION CATHETER | Medtronic Vascular | Mar 26, 2003 | SESE | | [K023878](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NFA/K023878.md) | GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM | Medtronic Vascular | Jan 24, 2003 | SESE | | [K013913](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NFA/K013913.md) | PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM | Medtronic Percusurge, Inc. | Nov 15, 2002 | SESE | | [K023303](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NFA/K023303.md) | EXPORT ASPIRATION CATHETER | Medtronic Vascular | Oct 29, 2002 | SESE | ## Top Applicants - Boston Scientific Corp — 4 clearances - Ev3, Inc. — 3 clearances - Kensey Nash Corp. — 3 clearances - Medtronic Vascular — 3 clearances - Boston Scientific Epi — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NFA](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NFA) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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