Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K052389 |
Device Name |
I-PORT |
Applicant |
PATTON MEDICAL DEVICES |
PO BOX 1490 |
EAGLE,
ID
83616
|
|
Applicant Contact |
FRED SCHLADOR |
Correspondent |
TUV AMERICA, INC. |
1775 OLD HIGHWAY 8 |
NEW BRIGHTON,
MN
55112 -1891
|
|
Correspondent Contact |
LAURA DANIELSON |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 08/31/2005 |
Decision Date | 09/09/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|