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FDA 510(k)

Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga

K-Number: K163537 · 2017-04-21

ApplicantCovidien, LLC
Decision Date2017-04-21
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2017-04-21 under approval number K163537. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga?

Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga is a medical device that received FDA 510(k) clearance on 2017-04-21. It is manufactured by Covidien, LLC. The 510(k) number is K163537.

When was Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga approved by the FDA?

Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga received FDA 510(k) clearance on 2017-04-21, under approval number K163537.

What company makes Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga?

Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga is manufactured by Covidien, LLC.

What is the FDA product code for Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga?

The FDA product code for Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga is EOQ.

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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.