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FDA 510(k)

Aspira Pleural Drainage System

K-Number: K212696 · 2023-03-03

ApplicantMerit Medical Systems, Inc.
Decision Date2023-03-03
Product CodeDWM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Aspira Pleural Drainage 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 2023-03-03 under 510(k) number K212696. The device is classified under product code DWM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aspira Pleural Drainage System?

Aspira Pleural Drainage System is a medical device that received FDA 510(k) clearance on 2023-03-03. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K212696.

When did Aspira Pleural Drainage System receive FDA 510(k) clearance?

Aspira Pleural Drainage System received FDA 510(k) clearance on 2023-03-03, under 510(k) number K212696.

Who is the listed applicant for Aspira Pleural Drainage 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 Aspira Pleural Drainage System?

The FDA product code for Aspira Pleural Drainage System is DWM.

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Related Devices (Code: DWM)

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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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