ATLANTIS PV


Device Classification Name

catheter, intravascular, diagnostic

510(k) Number K050684
Device Name ATLANTIS PV
Applicant
BOSTON SCIENTIFIC CORP.
47900 bayside parkway
fremont, 
CA 
94538 -6515

Applicant Contact robert z phillips
Correspondent
BOSTON SCIENTIFIC CORP.
47900 bayside parkway
fremont, 
CA 
94538 -6515

Correspodent Contact robert z phillips
Regulation Number 870.1200
Classification Product Code
DQO  
Subsequent Product Code
ITX  
Date Received 03/17/2005
Decision Date 05/20/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Radiology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No