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FDA 510(k)

TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II)

K-Number: K090961 · 2009-06-12

ApplicantTwin Star Medical, Inc.
Decision Date2009-06-12
Product CodeLXC
DecisionSubstantially Equivalent

Device Summary

TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II) is the device name listed in this FDA 510(k) record. The listed applicant is Twin Star Medical, Inc.. It received FDA 510(k) clearance on 2009-06-12 under 510(k) number K090961. The device is classified under product code LXC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II)?

TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II) is a medical device that received FDA 510(k) clearance on 2009-06-12. The listed applicant is Twin Star Medical, Inc.. The 510(k) number is K090961.

When did TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II) receive FDA 510(k) clearance?

TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II) received FDA 510(k) clearance on 2009-06-12, under 510(k) number K090961.

Who is the listed applicant for TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II)?

The FDA 510(k) record lists Twin Star Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II)?

The FDA product code for TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II) is LXC.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Twin Star Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K041771TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER SYSTEM

Related Devices (Code: LXC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251900MY01 Continuous Compartmental Pressure MonitorMY01, Inc.K242997MY01 Continuous Compartmental Pressure MonitorMY01, Inc.K223509Compremium Compartment Compressibility Monitoring System (CPM#1)Compremium AGK220952MY01 Continuous Compartmental Pressure MonitorMY01, Inc.K210525MY01 Continuous Compartmental Pressure MonitorMY01, Inc.K202635MY01 Continuous Compartmental Pressure MonitorMY01, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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