Device Classification Name |
Tubing, Pump, Cardiopulmonary Bypass
|
510(k) Number |
K142607 |
Device Name |
AngioVac Circuit |
Applicant |
ANGIODYNAMICS |
26 FOREST STREET |
MARLBOROUGH,
MA
01752
|
|
Applicant Contact |
Gary Barrett |
Correspondent |
ANGIODYNAMICS |
26 FOREST STREET |
MARLBOROUGH,
MA
01752
|
|
Correspondent Contact |
Gary Barrett |
Regulation Number | 870.4390
|
Classification Product Code |
|
Date Received | 09/15/2014 |
Decision Date | 12/11/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|