PleuraFlow System with FlowGlide— 510(k) K163139

Name: FDA 510(k) clearance K163139
Creator: U.S. Food and Drug Administration
Published: 2016-11-30

Substantially Equivalent

Clearflow, Inc.

FDA 510(k) clearance K163139 for PleuraFlow System with FlowGlide, Substantially Equivalent on 2016-11-30. Applicant: Clearflow, Inc.. Device class: 2.

Clearance details

Applicant: Clearflow, Inc.
Product code: Code OTK
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 2016-11-09
Decision date: 2016-11-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

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K153681 — PleuraFlow System2016-01-20
K150042 — PleuraFlow System2015-06-02

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