FDA 510(k)

AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters

K-Number: K173762 · 2018-07-18

Decision Date2018-07-18

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

AngioDynamics, Inc. Soft-Vu and Mariner Angiographic 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 2018-07-18 under 510(k) number K173762. 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 AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters?

AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters is a medical device that received FDA 510(k) clearance on 2018-07-18. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K173762.

When did AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters receive FDA 510(k) clearance?

AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters received FDA 510(k) clearance on 2018-07-18, under 510(k) number K173762.

Who is the listed applicant for AngioDynamics, Inc. Soft-Vu and Mariner Angiographic 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 AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters?

The FDA product code for AngioDynamics, Inc. Soft-Vu and Mariner Angiographic 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.