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Parker Quality & Compliance

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510(k) clearance

AngioVac F1885

FDA 510(k) source

510(k) number
K263076
Applicant
AngioDynamics, Inc.
Decision date
Oct 30, 2026
Date received
Sep 1, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
DWF
Device type
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class
Class II
Regulation
21 CFR 870.4210
Advisory committee
Cardiovascular
Statement or summary
Summary
Third party
N
Location
Queensbury, NY, US