Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K010880 |
Device Name |
NUMED HIGH PRESSURE PTA 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 |
|
Subsequent Product Code |
|
Date Received | 03/23/2001 |
Decision Date | 04/20/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|