510(k) K173762

AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters by AngioDynamics, Inc. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2018
Date Received
December 11, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type