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Found 6 results
510(k) Data Aggregation
K Number
K243553Device Name
QuikClot Control+ Hemostatic Device
Manufacturer
Teleflex Medical
Date Cleared
2025-03-18
(120 days)
Product Code
POD
Regulation Number
878.4454Why did this record match?
Product Code :
POD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
QuikClot Control+ is indicated for temporary control of external and identifiable sites of internal mild, moderate, severe, and life-threatening bleeding.
Device Description
QuikClot Control+™ Hemostatic Device consists of a white to yellow, sterile, X-Ray detectable hemostatic dressing and is packaged for aseptic removal.
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K Number
K213198Device Name
Ax-Surgi Surgical Hemostat
Manufacturer
Advamedica Inc.
Date Cleared
2023-01-05
(463 days)
Product Code
POD
Regulation Number
878.4454Why did this record match?
Product Code :
POD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ax-Surgi is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds and traumatic injuries.
Device Description
The Ax-Surgi Surgical Hemostat Surgical Hemostat is a sterile, single-use, surgical hemostatic patch. It is composed of a soft, lyophilized chitosan pad attached to a standard viscose-polyester gauze with a radiopaque element.
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K Number
K220971Device Name
QuikClot Control+ Hemostatic Dressing
Manufacturer
Z-Medica, LLC
Date Cleared
2022-12-14
(254 days)
Product Code
POD
Regulation Number
878.4454Why did this record match?
Product Code :
POD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
QuikClot Control+® Hemostatic Dressing is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries.
Cardiac surgical procedures: for temporary control of mild and moderate bleeding in cardiac surgical procedures, as well as in patients displaying class III or class IV bleeding.
Bone surfaces following sternotomy: to control bleeding from bone surfaces following a sternotomy.
Device Description
QuikClot Control+® Hemostatic Dressing is a prescription use non-absorbable device containing kaolin (hemostatic agent) bound to gauze. The hemostatic dressings are x-ray detectable and are provided as a single-use sterile device available in various sizes and configurations. The device is available in single or multipacks.
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K Number
K200167Device Name
QuikClot Control+
Manufacturer
Z-Medica, LLC
Date Cleared
2020-04-23
(91 days)
Product Code
POD
Regulation Number
878.4454Why did this record match?
Product Code :
POD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
QuikClot Control+® Hemostatic Dressing is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries.
Device Description
QuikClot Control+® Hemostatic Dressing is a prescription use non-absorbable device containing kaolin (hemostatic agent) bound to gauze. The hemostatic dressings are x-ray detectable and are provided as a single-use sterile device available in various sizes. The device is available in single or multipacks.
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K Number
K183190Device Name
NuStat
Manufacturer
Beeken Biomedical, LLC
Date Cleared
2019-09-25
(310 days)
Product Code
POD
Regulation Number
878.4454Why did this record match?
Product Code :
POD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NuStat is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries.
Device Description
The NuStat is a hemostatic wound dressing that is composed of continuous filament silica and bamboo cellulose rayon fiber and is provided with radiopaque thread. The distribution of cellulose and silica fibers in each dressing is 65% silica fiber and 35% bamboo cellulose rayon fiber. The dressings are available in various sizes and provided sterile in either foil, Tyvek, or LDPE pouched configurations. The NuStat hemostatic wound dressings have a number of hemostatic properties that enhance the ability of the dressing to temporarily control bleeding. NuStat Hemostatic Dressing's mode of action is via absorption of fluid, which results in a physical aggregation of blood cells and clotting factors at the site of application. The radiopaque element allows for detection via x-ray.
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K Number
DEN160012Device Name
D2 Dressing
Manufacturer
Z-MEDICA, LLC
Date Cleared
2017-06-30
(471 days)
Product Code
POD
Regulation Number
878.4454Why did this record match?
Product Code :
POD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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