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510(k) K090961

Device
TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II)
Applicant
TWIN STAR MEDICAL, INC.
510(k) number
K090961
Product code
LXC  
Decision
Substantially Equivalent (SESE)
Decision date
2009-06-12
Date received
2009-04-06
Regulation
510(k) Premarket Notification
Classification name
Monitor, Pressure, Intracompartmental
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Orthopedic
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GREGORY W SACHS
Address
5116 Birch Rd. Minnetonka MN US 55345 55345

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LXC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251900MY01 Continuous Compartmental Pressure MonitorMY01, Inc.2026-01-16
K242997MY01 Continuous Compartmental Pressure MonitorMY01, Inc.2025-03-13
K223509Compremium Compartment Compressibility Monitoring System (CPM#1)Compremium AG2023-04-14
K220952MY01 Continuous Compartmental Pressure MonitorMY01, Inc.2022-05-24
K210525MY01 Continuous Compartmental Pressure MonitorMY01, Inc.2021-04-22
K202635MY01 Continuous Compartmental Pressure MonitorMY01, Inc.2020-12-10
K193321MY01 Continuous Compartmental Pressure MonitorMY01, Inc.2020-07-30
K131966TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEMTwin Star Medical, Inc.2014-02-07
K060963TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS MONITOR)Twin Star Medical2006-06-06
K041771TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER SYSTEMTwin Star Medical, Inc.2004-09-14
K031555SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEMSynthes (Usa)2003-07-08
K881858ACE ICPM SIDE PORTED NEEDLEBuckman Co., Inc.1988-05-27
K873684ACE INTRA COMPARTMENTAL PRESSURE MONITORAce Medical Co.1988-01-20
K844214COMPARTMENT SYNDROME PRESSURE MONITOR SYSStryker Corp.1985-04-04

Legacy Summary#

summary

FDA Review#

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