BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER


Device Classification Name

catheter, intravascular, diagnostic

510(k) Number K022621
Device Name BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER
Original Applicant
BOSTON SCIENTIFIC CORP.
one boston scientific place
natick, 
MA 
01760

Original Contact heidi m erickson
Regulation Number 870.1200
Classification Product Code
DQO  
Date Received 08/07/2002
Decision Date 09/04/2002
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