FDA 510(k)

Spartan MC 0165

K-Number: K213451 · 2021-11-22

Decision Date2021-11-22

Product CodeQJP

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Spartan MC 0165 is the device name listed in this FDA 510(k) record. The listed applicant is Spartan Micro. It received FDA 510(k) clearance on 2021-11-22 under 510(k) number K213451. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spartan MC 0165?

Spartan MC 0165 is a medical device that received FDA 510(k) clearance on 2021-11-22. The listed applicant is Spartan Micro. The 510(k) number is K213451.

When did Spartan MC 0165 receive FDA 510(k) clearance?

Spartan MC 0165 received FDA 510(k) clearance on 2021-11-22, under 510(k) number K213451.

Who is the listed applicant for Spartan MC 0165?

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

What is the FDA product code for Spartan MC 0165?

The FDA product code for Spartan MC 0165 is QJP.

Other records listing Spartan Micro as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220716Spartan SC 069 K220075Spartan Center Wire K180653Spartan eCoil System

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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.