Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K945524 |
Device Name |
CORDIS INTRODUCING CATHETER |
Applicant |
CORDIS CORP. |
14201 N.W. 60TH AVE. |
MIAMI LAKES,
FL
33014
|
|
Applicant Contact |
KEVIN MACDONALD |
Correspondent |
CORDIS CORP. |
14201 N.W. 60TH AVE. |
MIAMI LAKES,
FL
33014
|
|
Correspondent Contact |
KEVIN MACDONALD |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 11/10/1994 |
Decision Date | 04/26/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|