Device Classification Name |
introducer, catheter
|
510(k) Number |
K861082 |
Device Name |
CORDIS CATH SHEATH INTRODUC/MID-LENGTH SHEATH SYST |
Applicant |
CORDIS CORP. |
P.O. BOX 025700 |
MIAMI,
FL
33102
|
|
Applicant Contact |
DONNA L ROGERS |
Correspondent |
CORDIS CORP. |
P.O. BOX 025700 |
MIAMI,
FL
33102
|
|
Correspondent Contact |
DONNA L ROGERS |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 03/21/1986 |
Decision Date | 05/05/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|