Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K945616 |
Device Name |
CORDIS AVANTI CATHETER SHEATH INTRODUCER |
Applicant |
CORDIS CORP. |
14201 N.W. 60TH AVE. |
MIAMI LAKES,
FL
33014
|
|
Applicant Contact |
TAMARA YOUNT |
Correspondent |
CORDIS CORP. |
14201 N.W. 60TH AVE. |
MIAMI LAKES,
FL
33014
|
|
Correspondent Contact |
TAMARA YOUNT |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 11/15/1994 |
Decision Date | 03/29/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|