Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K052004 |
Device Name |
VASCON NEUROPATH GUIDING CATHETER |
Applicant |
VASCON LLC |
4613 N. UNIVERSITY DRIVE |
SUITE 300 |
CORAL SPRINGS,
FL
33067
|
|
Applicant Contact |
ROBERTA D GOODE |
Correspondent |
VASCON LLC |
4613 N. UNIVERSITY DRIVE |
SUITE 300 |
CORAL SPRINGS,
FL
33067
|
|
Correspondent Contact |
ROBERTA D GOODE |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 07/25/2005 |
Decision Date | 01/19/2006 |
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
|
|
|