Atlas FDA

NFA

22 FDA 510(k) clearances · Product code

91 daysmedian time to decision
325 days90th percentile
22clearances measured

FDA profile

Official device name
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1250
Medical specialty
Cardiovascular
Adverse events (MAUDE)
2021: 25 · 2022: 23 · 2023: 22 · 2024: 55 · 2025: 92 · 2026: 31
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
INTERCEPTOR PLUS CORONARY FILTER SYSTEMS (K073523)Medtronic, Inc.2008-08-01
MODIFICATION TO PROXIS SYSTEM (K073563)St Jude Medical2008-01-31
SPIDERFX EMBOLIC PROTECTION DEVICE (K063785)Ev3, Inc.2007-01-19
TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 (K062870)Kensey Nash Corp.2006-10-20
PROXIS SYSTEM, MODEL EPS101 (K060651)St Jude Medical2006-09-13
PROXIS SYSTEM (K052523)Velocimed, Inc.2006-09-07
SPIDERX EMBOLIC PROTECTION DEVICE (K062201)Ev3, Inc.2006-08-11
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM) (K061332)Boston Scientific Corp2006-08-11
TRIACTIV FX EMBOLIC PROTECTION SYSTEM (K061772)Kensey Nash Corp.2006-07-11
SPIDERX EMBOLIC PROTECTION DEVICE (K053195)Ev3, Inc.2006-06-23
FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300 (K051984)Boston Scientific Corp2006-04-10
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (K052280)Boston Scientific Corp2005-11-07
EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150 (K051179)Boston Scientific Corp2005-06-08
TRIACTIV SYSTEM (K042040)Kensey Nash Corp.2005-03-23
FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH (K032884)Boston Scientific Epi2004-08-06
BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC (K023691)Boston Scientific Epi2003-06-04
MODIFICATION TO EXPORT ASPIRATION CATHETER (K030201)Medtronic Vascular2003-03-26
GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM (K023878)Medtronic Vascular2003-01-24
PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM (K013913)Medtronic Percusurge, Inc.2002-11-15
EXPORT ASPIRATION CATHETER (K023303)Medtronic Vascular2002-10-29
MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM (K014223)Medtronic Percusurge, Inc.2002-01-25
PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM (K003992)Percu Surge, Inc.2001-06-01

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Every clearance here is in the API, with alerts when new ones post.