ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER


Device Classification Name

catheter, ultrasound, intravascular

510(k) Number K111043
Device Name ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER
Applicant
BOSTON SCIENTIFIC CORP.
47900 bayside parkway
fremont, 
CA 
94538 -6515

Applicant Contact janice e brown, rac
Correspondent
BOSTON SCIENTIFIC CORP.
47900 bayside parkway
fremont, 
CA 
94538 -6515

Correspodent Contact janice e brown, rac
Regulation Number 870.1200
Classification Product Code
OBJ  
Subsequent Product Code
ITX  
Date Received 04/15/2011
Decision Date 08/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No