Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K033633 |
Device Name |
VASCON POLARIS GUIDING CATHETER |
Applicant |
VASCON LLC |
9344 NW 13 STREET |
MIAMI,
FL
33172
|
|
Applicant Contact |
STEPHEN F VADAS |
Correspondent |
VASCON LLC |
9344 NW 13 STREET |
MIAMI,
FL
33172
|
|
Correspondent Contact |
STEPHEN F VADAS |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 11/19/2003 |
Decision Date | 02/18/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|