EQUALIZER BALLOON CATHETER


Device Classification Name

catheter, percutaneous

510(k) Number K021721
Device Name EQUALIZER BALLOON CATHETER
Original Applicant
BOSTON SCIENTIFIC CORP.
one boston scientific place
natick, 
MA 
01760

Original Contact jennifer bolton
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 05/24/2002
Decision Date 06/20/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls