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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 a medical device manufactured by Clearflow, Inc.. It received FDA 510(k) clearance on 2019-07-26 under approval 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. It is manufactured by Clearflow, Inc.. The 510(k) number is K191733.

When was The ZIP Accessory Shuttle for PleuraFlow System approved by the FDA?

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

What company makes The ZIP Accessory Shuttle for PleuraFlow System?

The ZIP Accessory Shuttle for PleuraFlow System is manufactured by Clearflow, Inc..

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.

Related Clinical Trials

NCT05399537 Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT RECRUITING NCT04849884 To Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System. ACTIVE_NOT_RECRUITING

Other Devices by Clearflow, Inc.

K163139PleuraFlow System with FlowGlide K153681PleuraFlow System K182067PleuraFlow System with FlowGlide Extra Drainage Length K203394PleuraFlow System with FlowGlide

Related Devices (Code: OTK)

K163139PleuraFlow System with FlowGlideClearflow, Inc. K153681PleuraFlow SystemClearflow, Inc. K182067PleuraFlow System with FlowGlide Extra Drainage LengthClearflow, 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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