Device Classification Name |
Filter, Intravascular, Cardiovascular
|
510(k) Number |
K063217 |
Device Name |
VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL) |
Applicant |
B. BRAUN MEDICAL, INC. |
824 TWELFTH AVE. |
BETHLEHEM,
PA
18018
|
|
Applicant Contact |
PAUL O'CONNELL |
Correspondent |
B. BRAUN MEDICAL, INC. |
824 TWELFTH AVE. |
BETHLEHEM,
PA
18018
|
|
Correspondent Contact |
PAUL O'CONNELL |
Regulation Number | 870.3375
|
Classification Product Code |
|
Date Received | 10/24/2006 |
Decision Date | 01/12/2007 |
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
|
|
|