PleuraFlow System with FlowGlide— 510(k) K203394

Name: FDA 510(k) clearance K203394
Creator: U.S. Food and Drug Administration
Published: 2021-03-02

Substantially Equivalent

Clearflow, Inc.

FDA 510(k) clearance K203394 for PleuraFlow System with FlowGlide, Substantially Equivalent on 2021-03-02. 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: 2020-11-18
Decision date: 2021-03-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OTK

view all

K191733 — The ZIP Accessory Shuttle for PleuraFlow System2019-07-26
K182067 — PleuraFlow System with FlowGlide Extra Drainage Length2018-08-14
K163139 — PleuraFlow System with FlowGlide2016-11-30
K153681 — PleuraFlow System2016-01-20
K150042 — PleuraFlow System2015-06-02

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