Device Classification Name |
introducer, catheter
|
510(k) Number |
K945396 |
Device Name |
FLUORO-TIP(R) HEMOSTASIS VALVE INTRODUCER SET |
Applicant |
B. BRAUN MEDICAL, INC. |
13000 HWY. 55 |
PLYMOUTH,
MN
55441 -3813
|
|
Applicant Contact |
BARBARA ATZENHOEFER |
Correspondent |
B. BRAUN MEDICAL, INC. |
13000 HWY. 55 |
PLYMOUTH,
MN
55441 -3813
|
|
Correspondent Contact |
BARBARA ATZENHOEFER |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 11/03/1994 |
Decision Date | 03/13/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|