Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K042117 |
Device Name |
PROXIS SYSTEM, MODEL EPS 101 |
Applicant |
VELOCIMED INC. |
6550 WEDGWOOD RD. NORTH |
SUITE 150 |
MINNEAPOLIS,
MN
55311
|
|
Applicant Contact |
JOHN CARLINE |
Correspondent |
VELOCIMED INC. |
6550 WEDGWOOD RD. NORTH |
SUITE 150 |
MINNEAPOLIS,
MN
55311
|
|
Correspondent Contact |
JOHN CARLINE |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 08/05/2004 |
Decision Date | 01/07/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|