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FDA 510(k)

PleuraFlow System

K-Number: K153681 · 2016-01-20

ApplicantClearflow, Inc.
Decision Date2016-01-20
Product CodeOTK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PleuraFlow System is a medical device manufactured by Clearflow, Inc.. It received FDA 510(k) clearance on 2016-01-20 under approval number K153681. 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?

PleuraFlow System is a medical device that received FDA 510(k) clearance on 2016-01-20. It is manufactured by Clearflow, Inc.. The 510(k) number is K153681.

When was PleuraFlow System approved by the FDA?

PleuraFlow System received FDA 510(k) clearance on 2016-01-20, under approval number K153681.

What company makes PleuraFlow System?

PleuraFlow System is manufactured by Clearflow, Inc..

What is the FDA product code for PleuraFlow System?

The FDA product code for PleuraFlow System is OTK.

Other Devices by Clearflow, Inc.

K163139PleuraFlow System with FlowGlide K182067PleuraFlow System with FlowGlide Extra Drainage Length K191733The ZIP Accessory Shuttle for PleuraFlow System K203394PleuraFlow System with FlowGlide

Related Devices (Code: OTK)

K163139PleuraFlow System with FlowGlideClearflow, Inc. K182067PleuraFlow System with FlowGlide Extra Drainage LengthClearflow, Inc. K191733The ZIP Accessory Shuttle for PleuraFlow SystemClearflow, Inc. K203394PleuraFlow System with FlowGlideClearflow, 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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