Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K030589 |
Device Name |
MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS |
Applicant |
NUMED, INC. |
2880 MAIN ST. |
HOPKINTON,
NY
12965
|
|
Applicant Contact |
NICHELLE R LAFLESH |
Correspondent |
NUMED, INC. |
2880 MAIN ST. |
HOPKINTON,
NY
12965
|
|
Correspondent Contact |
NICHELLE R LAFLESH |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 02/25/2003 |
Decision Date | 05/21/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|