Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K032660 |
Device Name |
XTRAK SUPPORT CATHETER |
Applicant |
XTRAK MEDICAL INC. |
7 TIFFANY TRAIL |
HOPKINTON,
MA
01748
|
|
Applicant Contact |
DEBBIE IAMPIETRO |
Correspondent |
XTRAK MEDICAL INC. |
7 TIFFANY TRAIL |
HOPKINTON,
MA
01748
|
|
Correspondent Contact |
DEBBIE IAMPIETRO |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 08/28/2003 |
Decision Date | 10/29/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|