Device Classification Name |
Filter, Intravascular, Cardiovascular
|
510(k) Number |
K080668 |
FOIA Releasable 510(k) |
K080668
|
Device Name |
G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS |
Applicant |
C.R. BARD, INC. |
1625 WEST 3RD ST. |
TEMPE,
AZ
85281 -1740
|
|
Applicant Contact |
GENEVIEVE BALUTOWSKI |
Correspondent |
C.R. BARD, INC. |
1625 WEST 3RD ST. |
TEMPE,
AZ
85281 -1740
|
|
Correspondent Contact |
GENEVIEVE BALUTOWSKI |
Regulation Number | 870.3375
|
Classification Product Code |
|
Date Received | 03/10/2008 |
Decision Date | 07/30/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|