Device Classification Name |
introducer, catheter
|
510(k) Number |
K913801 |
Device Name |
CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL |
Applicant |
CORDIS CORP. |
14201 N.W. 60TH AVE. |
MIAMI LAKES,
FL
33014
|
|
Applicant Contact |
MIRJAM BARBOZA |
Correspondent |
CORDIS CORP. |
14201 N.W. 60TH AVE. |
MIAMI LAKES,
FL
33014
|
|
Correspondent Contact |
MIRJAM BARBOZA |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 08/26/1991 |
Decision Date | 10/16/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|