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FDA 510(k)

Cultura Collection and Transport System

K-Number: K201674 · 2021-03-03

Decision Date2021-03-03
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Cultura Collection and Transport System is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2021-03-03 under approval number K201674. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cultura Collection and Transport System?

Cultura Collection and Transport System is a medical device that received FDA 510(k) clearance on 2021-03-03. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K201674.

When was Cultura Collection and Transport System approved by the FDA?

Cultura Collection and Transport System received FDA 510(k) clearance on 2021-03-03, under approval number K201674.

What company makes Cultura Collection and Transport System?

Cultura Collection and Transport System is manufactured by Merit Medical Systems, Inc..

What is the FDA product code for Cultura Collection and Transport System?

The FDA product code for Cultura Collection and Transport System is JSM.

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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.