Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K904475 |
Device Name |
ENTREE SHEATH INTRODUCER SYSTEM |
Applicant |
CORDIS CORP. |
P.O. BOX 025700 |
MIAMI,
FL
33102
|
|
Applicant Contact |
PEGGY R SINGER |
Correspondent |
CORDIS CORP. |
P.O. BOX 025700 |
MIAMI,
FL
33102
|
|
Correspondent Contact |
PEGGY R SINGER |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 10/01/1990 |
Decision Date | 04/01/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|