Device Classification Name |
catheter, intravascular, diagnostic
|
510(k) Number |
K161596 |
Device Name |
Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters |
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 | 870.1200
|
Classification Product Code |
|
Date Received | 06/09/2016 |
Decision Date | 04/28/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|