PLEURAFLOW CATHETER SYSTEM— 510(k) K093565

Name: FDA 510(k) clearance K093565
Creator: U.S. Food and Drug Administration
Published: 2010-12-03

Substantially Equivalent

Clear Catheter Systems

FDA 510(k) clearance K093565 for PLEURAFLOW CATHETER SYSTEM, Substantially Equivalent on 2010-12-03. Applicant: Clear Catheter Systems. Device class: 2.

Clearance details

Applicant: Clear Catheter Systems
Product code: Code OTK
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 2009-11-18
Decision date: 2010-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alexandria, VA, US

Download summary PDF View on FDA.gov ↗

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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.