Device Classification Name |
Catheter, Intravascular, Diagnostic
|
510(k) Number |
K992631 |
Device Name |
ACUNAV DIAGNOSTIC ULTRASOUND CATHETER |
Applicant |
ACUSON CORP. |
555 13TH ST., N.W. |
WASHINGTON,
DC
20004 -1109
|
|
Applicant Contact |
HOWARD M HOLSTEIN |
Correspondent |
ACUSON CORP. |
555 13TH ST., N.W. |
WASHINGTON,
DC
20004 -1109
|
|
Correspondent Contact |
HOWARD M HOLSTEIN |
Regulation Number | 870.1200
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/06/1999 |
Decision Date | 12/15/1999 |
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
|
|
|