PleuraFlow System— 510(k) K150042

Substantially Equivalent

Clearflow, Inc.

FDA 510(k) clearance K150042 for PleuraFlow System, Substantially Equivalent on 2015-06-02. 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: 2015-01-09
Decision date: 2015-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OTK

K203394 — PleuraFlow System with FlowGlide2021-03-02
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

Data sourced from openFDA. This site is unofficial and independent of the FDA.