Device Classification Name |
Catheter, Intravascular, Diagnostic
|
510(k) Number |
K050577 |
Device Name |
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014 |
Applicant |
BOSTON SCIENTIFIC CORP. |
47201 LAKEVIEW BLVD. |
FREMONT,
CA
94537
|
|
Applicant Contact |
VERONICA M KOCKEN |
Correspondent |
BOSTON SCIENTIFIC CORP. |
47201 LAKEVIEW BLVD. |
FREMONT,
CA
94537
|
|
Correspondent Contact |
VERONICA M KOCKEN |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 03/07/2005 |
Decision Date | 03/30/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|