Device Classification Name |
Catheter, Intravascular, Diagnostic
|
510(k) Number |
K993694 |
Device Name |
MIKRO-TIP ANGIOGRAPHIC CATHETER |
Applicant |
MILLAR INSTRUMENTS, INC. |
6001 GULF FREEWAY, #534-G |
HOUSTON,
TX
77023 -5417
|
|
Applicant Contact |
MIRIELLE ARCE |
Correspondent |
MILLAR INSTRUMENTS, INC. |
6001 GULF FREEWAY, #534-G |
HOUSTON,
TX
77023 -5417
|
|
Correspondent Contact |
MIRIELLE ARCE |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 11/02/1999 |
Decision Date | 03/01/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|