ATLANTIS PVIMAGING CATHETER, MODEL H749364560


Device Classification Name

transducer, ultrasonic, diagnostic

510(k) Number K080272
Device Name ATLANTIS PVIMAGING CATHETER, MODEL H749364560
Applicant
BOSTON SCIENTIFIC CORP.
47900 bayside parkway
fremont, 
CA 
94538 -6515

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

Correspodent Contact janice brown
Regulation Number 892.1570
Classification Product Code
ITX  
Subsequent Product Code
OBJ  
Date Received 02/01/2008
Decision Date 03/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls