TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM— 510(k) K131966

Name: FDA 510(k) clearance K131966
Creator: U.S. Food and Drug Administration
Published: 2014-02-07

Substantially Equivalent

Twin Star Medical, Inc.

FDA 510(k) clearance K131966 for TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM, Substantially Equivalent on 2014-02-07. Applicant: Twin Star Medical, Inc.. Device class: Unclassified.

Clearance details

Applicant: Twin Star Medical, Inc.
Product code: Code LXC
Device class: Unclassified
Advisory panel: Unknown
Date received: 2013-06-28
Decision date: 2014-02-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

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