FDA.report

510(k) K173762

Device
AngioDynamics, Inc. Soft-Vu And Mariner Angiographic Catheters
Applicant
AngioDynamics, Inc.
510(k) number
K173762
Product code
DQO  
Decision
Substantially Equivalent (SESE)
Decision date
2018-07-18
Date received
2017-12-11
Regulation
870.1200
Classification name
Catheter, Intravascular, Diagnostic
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Teri Juckett
Address
603 Queensbury Ave. Queensburgy NY US 12804 12804

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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Legacy Summary

summary

FDA Review

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