ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975


Device Classification Name

catheter, intravascular, diagnostic

510(k) Number K010707
Device Name ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975
Original Applicant
BOSTON SCIENTIFIC, TARGET
47900 bayside pkwy.
fremont, 
CA 
94538

Original Contact irene jaworski
Regulation Number 870.1200
Classification Product Code
DQO  
Subsequent Product Code
ITX  
Date Received 03/09/2001
Decision Date 03/29/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Radiology

Type Special
Reviewed by Third Party No

Combination Product

No