FDA 510(k)

NAMIC ClearaCIL Contrast Injection Lines

K-Number: K163141 · 2017-01-06

Decision Date2017-01-06

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

NAMIC ClearaCIL Contrast Injection Lines is the device name listed in this FDA 510(k) record. The listed applicant is AngioDynamics, Inc.. It received FDA 510(k) clearance on 2017-01-06 under 510(k) number K163141. 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 NAMIC ClearaCIL Contrast Injection Lines?

NAMIC ClearaCIL Contrast Injection Lines is a medical device that received FDA 510(k) clearance on 2017-01-06. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K163141.

When did NAMIC ClearaCIL Contrast Injection Lines receive FDA 510(k) clearance?

NAMIC ClearaCIL Contrast Injection Lines received FDA 510(k) clearance on 2017-01-06, under 510(k) number K163141.

Who is the listed applicant for NAMIC ClearaCIL Contrast Injection Lines?

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 NAMIC ClearaCIL Contrast Injection Lines?

The FDA product code for NAMIC ClearaCIL Contrast Injection Lines 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.