Device Classification Name |
port & catheter, implanted, subcutaneous, intravascular
|
510(k) Number |
K101017 |
Device Name |
ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS |
Applicant |
ANGIODYNAMICS, INC. |
603 QUEENSBURY AVE. |
QUEENSBURY,
NY
12804
|
|
Applicant Contact |
S. MICHAEL SHARP |
Correspondent |
ANGIODYNAMICS, INC. |
603 QUEENSBURY AVE. |
QUEENSBURY,
NY
12804
|
|
Correspondent Contact |
S. MICHAEL SHARP |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 04/12/2010 |
Decision Date | 06/17/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|