Device Classification Name |
catheter, septostomy
|
510(k) Number |
K011557 |
Device Name |
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING 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 | 870.5175
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/21/2001 |
Decision Date | 07/12/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|