BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC


Device Classification Name

temporary coronary saphenous vein bypass graft for embolic protection

510(k) Number K023691
Device Name BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC
Original Applicant
BOSTON SCIENTIFIC EPI
2525 walsh ave.
santa clara, 
CA 
95051 -1316

Original Contact timothy j johnson
Regulation Number 870.1250
Classification Product Code
NFA  
Date Received 11/01/2002
Decision Date 06/04/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No