Device Classification Name |
catheter, ultrasound, intravascular
|
510(k) Number |
K033650 |
Device Name |
ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
1230 SHOREBIRD WAY |
MOUNTAIN VIEW,
CA
94039 -7393
|
|
Applicant Contact |
ISKRA MRAKOVIC |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
1230 SHOREBIRD WAY |
MOUNTAIN VIEW,
CA
94039 -7393
|
|
Correspondent Contact |
ISKRA MRAKOVIC |
Regulation Number | 870.1200
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/20/2003 |
Decision Date | 02/24/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|