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FDA 510(k)

The ZIP Accessory Shuttle for PleuraFlow System

K-Number: K191733 · 2019-07-26

ApplicantClearflow, Inc.
Decision Date2019-07-26
Product CodeOTK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

The ZIP Accessory Shuttle for PleuraFlow System is the device name listed in this FDA 510(k) record. The listed applicant is Clearflow, Inc.. It received FDA 510(k) clearance on 2019-07-26 under 510(k) number K191733. 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 The ZIP Accessory Shuttle for PleuraFlow System?

The ZIP Accessory Shuttle for PleuraFlow System is a medical device that received FDA 510(k) clearance on 2019-07-26. The listed applicant is Clearflow, Inc.. The 510(k) number is K191733.

When did The ZIP Accessory Shuttle for PleuraFlow System receive FDA 510(k) clearance?

The ZIP Accessory Shuttle for PleuraFlow System received FDA 510(k) clearance on 2019-07-26, under 510(k) number K191733.

Who is the listed applicant for The ZIP Accessory Shuttle for PleuraFlow System?

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 The ZIP Accessory Shuttle for PleuraFlow System?

The FDA product code for The ZIP Accessory Shuttle for PleuraFlow System 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 FlowGlideK182067PleuraFlow System with FlowGlide Extra Drainage LengthK163139PleuraFlow 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.K182067PleuraFlow System with FlowGlide Extra Drainage LengthClearflow, Inc.K163139PleuraFlow System with FlowGlideClearflow, Inc.K153681PleuraFlow SystemClearflow, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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