Device Classification Name |
introducer, catheter
|
510(k) Number |
K964034 |
FOIA Releasable 510(k) |
K964034
|
Device Name |
TRANSJUGULAR ACCESS SET |
Applicant |
ANGIODYNAMICS, INC. |
603 QUEENSBURY AVE. |
QUEENSBURY,
NY
12804
|
|
Applicant Contact |
BRIAN KUNST |
Correspondent |
ANGIODYNAMICS, INC. |
603 QUEENSBURY AVE. |
QUEENSBURY,
NY
12804
|
|
Correspondent Contact |
BRIAN KUNST |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 10/08/1996 |
Decision Date | 05/06/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|