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510(k) K041771

Device
TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER SYSTEM
Applicant
TWIN STAR MEDICAL, INC.
510(k) number
K041771
Product code
LXC  
Decision
Substantially Equivalent (SESE)
Decision date
2004-09-14
Date received
2004-06-30
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
JONATHAN KAHAN
Address
555 13th St., NW Washington DC US 20004 20004

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
K090961TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II)Twin Star Medical, Inc.2009-06-12
K060963TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS MONITOR)Twin Star Medical2006-06-06
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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