Device Classification Name |
introducer, catheter
|
510(k) Number |
K971608 |
Device Name |
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM |
Applicant |
CORDIS CORP. |
14201 N.W. 60TH AVE. |
MIAMI LAKES,
FL
33014
|
|
Applicant Contact |
ELENA S JUGO |
Correspondent |
CORDIS CORP. |
14201 N.W. 60TH AVE. |
MIAMI LAKES,
FL
33014
|
|
Correspondent Contact |
ELENA S JUGO |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 05/01/1997 |
Decision Date | 07/21/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|