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FDA 510(k)

Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters

K-Number: K161596 · 2017-04-28

ApplicantAngioDynamics, Inc.
Decision Date2017-04-28
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters is a medical device manufactured by AngioDynamics, Inc.. It received FDA 510(k) clearance on 2017-04-28 under approval number K161596. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters?

Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters is a medical device that received FDA 510(k) clearance on 2017-04-28. It is manufactured by AngioDynamics, Inc.. The 510(k) number is K161596.

When was Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters approved by the FDA?

Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters received FDA 510(k) clearance on 2017-04-28, under approval number K161596.

What company makes Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters?

Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters is manufactured by AngioDynamics, Inc..

What is the FDA product code for Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters?

The FDA product code for Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters is DQO.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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