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FDA 510(k)

Cultura Collection and Transport System

K-Number: K201674 · 2021-03-03

ApplicantMerit Medical Systems, Inc.
Decision Date2021-03-03
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Cultura Collection and Transport System is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2021-03-03 under 510(k) 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. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K201674.

When did Cultura Collection and Transport System receive FDA 510(k) clearance?

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

Who is the listed applicant for Cultura Collection and Transport System?

The FDA 510(k) record lists Merit Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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