Product code NFA— Cardiovascular
SPIDERX EMBOLIC PROTECTION DEVICE
- Classification name
- Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Total cleared
- 22
- First cleared
- Most recent
Market context for product code NFA
FDA has cleared devices under product code NFA between 2001 and 2008, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
- 2001
Top applicants under product code NFA
Recent clearances under product code NFA
- K073523 — INTERCEPTOR PLUS CORONARY FILTER SYSTEMS
- K073563 — MODIFICATION TO PROXIS SYSTEM
- K063785 — SPIDERFX EMBOLIC PROTECTION DEVICE
- K062870 — TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03
- K060651 — PROXIS SYSTEM, MODEL EPS101
- K052523 — PROXIS SYSTEM
- K061332 — FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM)
- K062201 — SPIDERX EMBOLIC PROTECTION DEVICE
- K061772 — TRIACTIV FX EMBOLIC PROTECTION SYSTEM
- K053195 — SPIDERX EMBOLIC PROTECTION DEVICE
- K051984 — FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300
- K052280 — FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM
- K051179 — EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150
- K042040 — TRIACTIV SYSTEM
- K032884 — FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH
- K023691 — BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC
- K030201 — MODIFICATION TO EXPORT ASPIRATION CATHETER
- K023878 — GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
- K013913 — PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
- K023303 — EXPORT ASPIRATION CATHETER
- K014223 — MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM
- K003992 — PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.