510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K032884Substantially Equivalent

Filter Wire Ez Embolic Protection System and Ez Bent Tip Retrieval Sheath

Boston Scientific Epi, Santa Clara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032884 is the FDA 510(k) clearance record for FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH, a class II device, cleared for Boston Scientific Epi on under FDA product code NFA (Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection). FDA records list 2 510(k) clearances for Boston Scientific Epi, from to . As of , FDA records show no recalls naming K032884.

Clearance record

Decision date
Received
(325 days to decision)
Product code
NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Boston Scientific Epi 2525 Walsh Ave., Santa Clara CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NFA

Trailing 12 months

FDA records hold no clearances under product code NFA in the trailing twelve months.

FDA records show no clearances under product code NFA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NFA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260