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FDA 510(k)

PLEURAFLOW CATHETER SYSTEM

K-Number: K093565 · 2010-12-03

ApplicantClear Catheter Systems
Decision Date2010-12-03
Product CodeOTK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PLEURAFLOW CATHETER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Clear Catheter Systems. It received FDA 510(k) clearance on 2010-12-03 under 510(k) number K093565. 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 CATHETER SYSTEM?

PLEURAFLOW CATHETER SYSTEM is a medical device that received FDA 510(k) clearance on 2010-12-03. The listed applicant is Clear Catheter Systems. The 510(k) number is K093565.

When did PLEURAFLOW CATHETER SYSTEM receive FDA 510(k) clearance?

PLEURAFLOW CATHETER SYSTEM received FDA 510(k) clearance on 2010-12-03, under 510(k) number K093565.

Who is the listed applicant for PLEURAFLOW CATHETER SYSTEM?

The FDA 510(k) record lists Clear Catheter Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLEURAFLOW CATHETER SYSTEM?

The FDA product code for PLEURAFLOW CATHETER SYSTEM is OTK.

Related Clinical Trials

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.

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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.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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