Device Classification Name |
filter, intravascular, cardiovascular
|
510(k) Number |
K082305 |
Device Name |
G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS |
Applicant |
C.R. BARD, INC. |
1625 WEST 3RD ST. |
P.O. BOX 1740 |
TEMPE,
AZ
85280 -1740
|
|
Applicant Contact |
GENEVIEVE BALUTOWSKI |
Correspondent |
C.R. BARD, INC. |
1625 WEST 3RD ST. |
P.O. BOX 1740 |
TEMPE,
AZ
85280 -1740
|
|
Correspondent Contact |
GENEVIEVE BALUTOWSKI |
Regulation Number | 870.3375
|
Classification Product Code |
|
Date Received | 08/13/2008 |
Decision Date | 10/31/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|