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Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection

FDA product code NFA · Class 2 · Cardiovascular

19
Registered devices
2,032
Adverse events
4
Recalls
22
510(k) clearances

Devices with this code

GuardWire® — MEDTRONIC, INC.SpiderFX — Covidien LPFilterWire EZ™ — BOSTON SCIENTIFIC CORPORATIONSpiderFX — Covidien LPSpiderFX — Covidien LPSpiderFX — Covidien LPSpiderFX — Covidien LPSpiderFX — Covidien LPFilterWire EZ™ — BOSTON SCIENTIFIC CORPORATIONSpiderFX — Covidien LPGuardWire® — MEDTRONIC, INC.SpiderFX — Covidien LPGuardWire® — MEDTRONIC, INC.FilterWire EZ™ — BOSTON SCIENTIFIC CORPORATIONSpiderFX — Covidien LPSpiderFX — Covidien LPGuardWire® — MEDTRONIC, INC.FilterWire EZ™ — BOSTON SCIENTIFIC CORPORATIONEZ Bent Tip — BOSTON SCIENTIFIC CORPORATION

Recent recalls

DateFirmReason
2006-05-24Kensey Nash CorpVolume control knob not able to go up to larger diameters
2006-05-24Kensey Nash Corpvolume control knob not able to go up to larger diameters
2006-05-24Kensey Nash Corpvolume control knob not able to go up to larger diameters
2006-04-06Kensey Nash CorpAlarm activiation-A priming issue involving the flow control unit due to a software problem has caused false postive Extraction Line Block (ELB) alarming. Use

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.