FDA 510(k)

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

K-Number: K161596 · 2017-04-28

Decision Date2017-04-28

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters is the device name listed in this FDA 510(k) record. The listed applicant is AngioDynamics, Inc.. It received FDA 510(k) clearance on 2017-04-28 under 510(k) 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. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K161596.

When did Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters receive FDA 510(k) clearance?

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

Who is the listed applicant for Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters?

The FDA 510(k) record lists AngioDynamics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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