Device Classification Name |
filter, intravascular, cardiovascular
|
510(k) Number |
K120402 |
Device Name |
CRUX VENA CAVA FILTER SYSTEM |
Applicant |
CRUX BIOMEDICAL |
1455 ADAMS DRIVE, #1170 |
MENLO PARK,
CA
94025
|
|
Applicant Contact |
ELISA HEBB |
Correspondent |
CRUX BIOMEDICAL |
1455 ADAMS DRIVE, #1170 |
MENLO PARK,
CA
94025
|
|
Correspondent Contact |
ELISA HEBB |
Regulation Number | 870.3375
|
Classification Product Code |
|
Date Received | 02/08/2012 |
Decision Date | 07/13/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01120509 NCT01120522 NCT01120535
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|