Device Classification Name |
Cannula, Catheter
|
510(k) Number |
K051655 |
Device Name |
ANGIODYNAMICS, INC., MICRO ACCESS KITS |
Applicant |
ANGIODYNAMICS, INC. |
603 QUEENSBURY AVE. |
QUEENSBURY,
NY
12804
|
|
Applicant Contact |
TERI JUCKETT |
Correspondent |
ANGIODYNAMICS, INC. |
603 QUEENSBURY AVE. |
QUEENSBURY,
NY
12804
|
|
Correspondent Contact |
TERI JUCKETT |
Regulation Number | 870.1300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/21/2005 |
Decision Date | 09/12/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|