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FDA 510(k)

PleuraFlow System with FlowGlide Extra Drainage Length

K-Number: K182067 · 2018-08-14

ApplicantClearflow, Inc.
Decision Date2018-08-14
Product CodeOTK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PleuraFlow System with FlowGlide Extra Drainage Length is a medical device manufactured by Clearflow, Inc.. It received FDA 510(k) clearance on 2018-08-14 under approval number K182067. 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 Extra Drainage Length?

PleuraFlow System with FlowGlide Extra Drainage Length is a medical device that received FDA 510(k) clearance on 2018-08-14. It is manufactured by Clearflow, Inc.. The 510(k) number is K182067.

When was PleuraFlow System with FlowGlide Extra Drainage Length approved by the FDA?

PleuraFlow System with FlowGlide Extra Drainage Length received FDA 510(k) clearance on 2018-08-14, under approval number K182067.

What company makes PleuraFlow System with FlowGlide Extra Drainage Length?

PleuraFlow System with FlowGlide Extra Drainage Length is manufactured by Clearflow, Inc..

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

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

Related Clinical Trials

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Related PubMed Literature

PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

Other Devices by Clearflow, Inc.

K163139PleuraFlow System with FlowGlide K153681PleuraFlow System K191733The ZIP Accessory Shuttle for PleuraFlow System K203394PleuraFlow System with FlowGlide

Related Devices (Code: OTK)

K163139PleuraFlow System with FlowGlideClearflow, Inc. K153681PleuraFlow SystemClearflow, 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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