Device Classification Name |
filter, intravascular, cardiovascular
|
510(k) Number |
K003964 |
Device Name |
TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B |
Applicant |
CORDIS CORP. |
7 POWDER HORN DR. |
WARREN,
NJ
07059
|
|
Applicant Contact |
KAREN WILK |
Correspondent |
CORDIS CORP. |
7 POWDER HORN DR. |
WARREN,
NJ
07059
|
|
Correspondent Contact |
KAREN WILK |
Regulation Number | 870.3375
|
Classification Product Code |
|
Date Received | 12/22/2000 |
Decision Date | 01/19/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|