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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 the device name listed in this FDA 510(k) record. The listed applicant is Clearflow, Inc.. It received FDA 510(k) clearance on 2018-08-14 under 510(k) 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. The listed applicant is Clearflow, Inc.. The 510(k) number is K182067.

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

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

Who is the listed applicant for PleuraFlow System with FlowGlide Extra Drainage Length?

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 Extra Drainage Length?

The FDA product code for PleuraFlow System with FlowGlide Extra Drainage Length 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 SystemK163139PleuraFlow System with FlowGlideK153681PleuraFlow 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.K163139PleuraFlow System with FlowGlideClearflow, 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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