510(k) K253106

AngioVac Cannula by AngioDynamics, Inc. — Product Code DWF

K253106 is an FDA 510(k) premarket notification submitted by AngioDynamics, Inc. for the device "AngioVac Cannula". The FDA issued a decision of Substantially Equivalent on October 24, 2025. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. AngioDynamics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2025
Date Received
September 24, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4210
Review Panel
CV
Submission Type