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FDA 510(k)

PleuraFlow System with FlowGlide

K-Number: K163139 · 2016-11-30

ApplicantClearflow, Inc.
Decision Date2016-11-30
Product CodeOTK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PleuraFlow System with FlowGlide is the device name listed in this FDA 510(k) record. The listed applicant is Clearflow, Inc.. It received FDA 510(k) clearance on 2016-11-30 under 510(k) number K163139. 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 2016-11-30. The listed applicant is Clearflow, Inc.. The 510(k) number is K163139.

When did PleuraFlow System with FlowGlide receive FDA 510(k) clearance?

PleuraFlow System with FlowGlide received FDA 510(k) clearance on 2016-11-30, under 510(k) number K163139.

Who is the listed applicant for PleuraFlow System with FlowGlide?

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

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

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

Other records listing Clearflow, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203394PleuraFlow System with FlowGlideK191733The ZIP Accessory Shuttle for PleuraFlow SystemK182067PleuraFlow System with FlowGlide Extra Drainage LengthK153681PleuraFlow System

Related Devices (Code: OTK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203394PleuraFlow System with FlowGlideClearflow, Inc.K191733The ZIP Accessory Shuttle for PleuraFlow SystemClearflow, Inc.K182067PleuraFlow System with FlowGlide Extra Drainage LengthClearflow, Inc.K153681PleuraFlow 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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