Device Classification Name |
catheter, electrode recording, or probe, electrode recording
|
510(k) Number |
K081576 |
Device Name |
BLAZER DX-20 DIAGNOSTIC CATHETER |
Applicant |
BOSTON SCIENTIFIC CORP. |
150 BAYTECH DRIVE |
SAN JOSE,
CA
95134
|
|
Applicant Contact |
RONALD C ALLEN |
Correspondent |
BOSTON SCIENTIFIC CORP. |
150 BAYTECH DRIVE |
SAN JOSE,
CA
95134
|
|
Correspondent Contact |
RONALD C ALLEN |
Regulation Number | 870.1220
|
Classification Product Code |
|
Date Received | 06/05/2008 |
Decision Date | 02/03/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|