ATLANTIS 018 PERIPHERAL IMAGING CATHETER


Device Classification Name

transducer, ultrasonic, diagnostic

510(k) Number K073623
Device Name ATLANTIS 018 PERIPHERAL IMAGING CATHETER
Applicant
BOSTON SCIENTIFIC CORP.
47900 bayside parkway
fremont, 
CA 
94538 -6515

Applicant Contact emilly tojima
Correspondent
BOSTON SCIENTIFIC CORP.
47900 bayside parkway
fremont, 
CA 
94538 -6515

Correspodent Contact emilly tojima
Regulation Number 892.1570
Classification Product Code
ITX  
Subsequent Product Code
OBJ  
Date Received 12/26/2007
Decision Date 03/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No