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510(k) K090961

TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II) by Twin Star Medical, Inc. — Product Code LXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2009
Date Received
April 6, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Pressure, Intracompartmental
Device Class
Class U
Regulation Number
Review Panel
OR
Submission Type

Other clearances by Twin Star Medical, Inc.

  • K131966 — TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER S (February 7, 2014)
  • K060963 — TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS MONI (June 6, 2006)
  • K041771 — TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER (September 14, 2004)

Other clearances for product code LXC

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  • K242997 — MY01 Continuous Compartmental Pressure Monitor (March 13, 2025)
  • K223509 — Compremium Compartment Compressibility Monitoring System (CPM#1) (April 14, 2023)
  • K220952 — MY01 Continuous Compartmental Pressure Monitor (May 24, 2022)
  • K210525 — MY01 Continuous Compartmental Pressure Monitor (April 22, 2021)
  • K202635 — MY01 Continuous Compartmental Pressure Monitor (December 10, 2020)
  • K193321 — MY01 Continuous Compartmental Pressure Monitor (July 30, 2020)
  • K131966 — TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER S (February 7, 2014)
  • K060963 — TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS MONI (June 6, 2006)
  • K041771 — TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER (September 14, 2004)