Device Classification Name |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
|
510(k) Number |
K190594 |
Device Name |
AngioVac C20, AngioVac C180 |
Applicant |
AngioDynamics, Inc. |
26 Forest St. |
Marlborough,
MA
01752
|
|
Applicant Contact |
Kasey Newcomb |
Correspondent |
AngioDynamics, Inc. |
26 Forest St. |
Marlborough,
MA
01752
|
|
Correspondent Contact |
Kasey Newcomb |
Regulation Number | 870.4210 |
Classification Product Code |
|
Date Received | 03/07/2019 |
Decision Date | 07/05/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|