Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K931102 |
Device Name |
CORDIS NIHON CATHETER SHEATH INTRODUCER |
Applicant |
CORDIS CORP. |
P.O. BOX 025700 |
MIAMI,
FL
33102
|
|
Applicant Contact |
TYE R MINNICK |
Correspondent |
CORDIS CORP. |
P.O. BOX 025700 |
MIAMI,
FL
33102
|
|
Correspondent Contact |
TYE R MINNICK |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 03/03/1993 |
Decision Date | 05/27/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|