Device Classification Name |
introducer, catheter
|
510(k) Number |
K855126 |
Device Name |
CORDIS CATHETER SHEATH INTRODUCERS,STERI-SLEEVES |
Applicant |
CORDIS CORP. |
POST OFFICE BOX 025700 |
MIAMI,
FL
33102 -5700
|
|
Applicant Contact |
DONNA L ROGERS |
Correspondent |
CORDIS CORP. |
POST OFFICE BOX 025700 |
MIAMI,
FL
33102 -5700
|
|
Correspondent Contact |
DONNA L ROGERS |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 12/23/1985 |
Decision Date | 02/26/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|