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FDA 510(k)

PleuraFlow System with FlowGlide

K-Number: K203394 · 2021-03-02

ApplicantClearflow, Inc.
Decision Date2021-03-02
Product CodeOTK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PleuraFlow System with FlowGlide is a medical device manufactured by Clearflow, Inc.. It received FDA 510(k) clearance on 2021-03-02 under approval number K203394. The device is classified under product code OTK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PleuraFlow System with FlowGlide?

PleuraFlow System with FlowGlide is a medical device that received FDA 510(k) clearance on 2021-03-02. It is manufactured by Clearflow, Inc.. The 510(k) number is K203394.

When was PleuraFlow System with FlowGlide approved by the FDA?

PleuraFlow System with FlowGlide received FDA 510(k) clearance on 2021-03-02, under approval number K203394.

What company makes PleuraFlow System with FlowGlide?

PleuraFlow System with FlowGlide is manufactured by Clearflow, Inc..

What is the FDA product code for PleuraFlow System with FlowGlide?

The FDA product code for PleuraFlow System with FlowGlide is OTK.

Other Devices by Clearflow, Inc.

K163139PleuraFlow System with FlowGlide K153681PleuraFlow System K182067PleuraFlow System with FlowGlide Extra Drainage Length K191733The ZIP Accessory Shuttle for PleuraFlow System

Related Devices (Code: OTK)

K163139PleuraFlow System with FlowGlideClearflow, Inc. K153681PleuraFlow SystemClearflow, Inc. K182067PleuraFlow System with FlowGlide Extra Drainage LengthClearflow, Inc. K191733The ZIP Accessory Shuttle for PleuraFlow SystemClearflow, Inc.

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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