Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K021094 |
FOIA Releasable 510(k) |
K021094
|
Device Name |
INTROCAN SAFETY IV CATHETER |
Applicant |
B. BRAUN MEDICAL, INC. |
901 MARCON BLVD. |
ALLENTOWN,
PA
18109
|
|
Applicant Contact |
PATRICIA D WILSON |
Correspondent |
B. BRAUN MEDICAL, INC. |
901 MARCON BLVD. |
ALLENTOWN,
PA
18109
|
|
Correspondent Contact |
PATRICIA D WILSON |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 04/04/2002 |
Decision Date | 07/03/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|