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Found 3 results
510(k) Data Aggregation
K Number
K141685Device Name
CROC
Manufacturer
COMBAT MEDICAL SYSTEMS, LLC
Date Cleared
2015-01-26
(217 days)
Product Code
DXC
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
COMBAT MEDICAL SYSTEMS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CRoC™ is indicated for use in the battlefield to control difficult bleeds in the inguinal and axilla areas. The CRoC is also indicated for use in the battlefield as a last resort for life threatening bleeds of the carotid artery.
Device Description
The CRoC™ is designed to be used by emergency medical personnel in the battlefield. The device is designed to control bleeding in anatomical areas where standard tourniquets cannot be used. The device can be used instead of manual pressure, allowing the medic to attend to other injuries. The CRoC™ is used to control a difficult bleed for up to 4 hours until the injured can be transferred to evacuation personnel or other medical personnel for further treatment.
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K Number
K130482Device Name
COMBAT READY CLAMP
Manufacturer
COMBAT MEDICAL SYSTEMS, LLC
Date Cleared
2013-04-29
(63 days)
Product Code
DXC
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
COMBAT MEDICAL SYSTEMS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Combat Ready Clamp is indicated for use in the battlefield to control difficult bleeds in the inguinal and axilla areas.
Device Description
The CRoC™ is designed to be used by emergency medical personnel in the battlefield. The device is designed to control bleeding in anatomical areas where standard tourniquets cannot be used. The device can be used instead of manual pressure, allowing the medic to attend to other injuries. The Combat Ready Clamp is used to control a difficult bleed for up to 4 hours until the injured can be transferred to evacuation personnel or other medical personnel for further treatment.
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K Number
K102025Device Name
COMBAT READY CLAMP
Manufacturer
COMBAT MEDICAL SYSTEMS, LLC
Date Cleared
2010-08-11
(23 days)
Product Code
DXC
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
COMBAT MEDICAL SYSTEMS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Combat Ready Clamp is indicated for use in the battlefield to control difficult bleeds in the inguinal area.
Device Description
The Combat Ready Clamp is designed to be used by Military medical personnel in the battlefield. The device is designed to control bleeding in the inguinal area where standard tourniquets cannot be used. The device can be used instead of manual pressure, allowing the medic to attend to other injuries or soldiers. The Combat Ready Clamp is used to control a difficult bleed for up to 4 hours until the injured soldier can be transferred to evacuation personnel for further treatment.
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