K202347

Substantially Equivalent

UNIFUSE Infusion System with Cooper Wire

Applicant: AngioDynamics, Inc.
Product code: QEY
Advisory panel: Cardiovascular
Date received: 2020-08-18
Decision date: 2020-09-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Marlborough, MA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.