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510(k) Data Aggregation
K Number
K112838Device Name
VASOPRESS REPROCESSED DVT LEG / FOOT GARMENTS
Manufacturer
COMPRESSION THERAPY CONCEPTS, INC.
Date Cleared
2011-11-10
(43 days)
Product Code
JOW, PRO
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
COMPRESSION THERAPY CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DVT Garment is an external pneumatic compression device intended to lower the risk of deep vein thrombosis (DVT) and resulting pulmonary embolism (PE) in patients who may be at risk for thrombosis formation.
Device Description
The VasoPress Reprocessed DVT Leg Garment consists of a brushed nylon outer material bonded to a foam inner liner bonded to a tricot lining. An inflatable polyvinylchloride (PVC) pressure bag is encapsulated between an additional nylon/foam material. The VasoPress Reprocessed DVT Foot Garment has the same outer shell with a polyurethane (PU) pressure bag inside. An exit tube leads out from the pressure bag for connection to the VasoPress Pump. The device is automatically inflated by a pneumatic pump. The patient contact material is tricot over polyurethane foam. The reprocessed devices are cleaned, inspected and tested, packaged and exposed to Ethylene Oxide (EO) gas wash. The VasoPress Reprocessed DVT Garments are provided non-sterile.
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K Number
K101915Device Name
VASOPRESS SUPREME MINI MODEL VP500DM
Manufacturer
COMPRESSION THERAPY CONCEPTS, INC.
Date Cleared
2010-08-06
(28 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
COMPRESSION THERAPY CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VasoPress Pump (Model VP500DM) is an external pneumatic compression device for use with VasoPress DVT garments, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.
Device Description
VasoPress DVT Supreme Mini, Pump Model No. VP500DM
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K Number
K061814Device Name
VASOPRESS DVT SYSTEM, MODEL VP500D
Manufacturer
COMPRESSION THERAPY CONCEPTS, INC.
Date Cleared
2006-11-30
(156 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
COMPRESSION THERAPY CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VasoPress pump (VP500D) is an external pneumatic compression device for use with VasoPress DVT garments, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.
Device Description
VasoPress DVT System, Pump Model VP500D
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K Number
K061967Device Name
SCD GARMENT, MODEL VP530
Manufacturer
COMPRESSION THERAPY CONCEPTS, INC.
Date Cleared
2006-09-25
(75 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
COMPRESSION THERAPY CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VasoQuential is designed to increase venous blood flow in at The Vasoquencear in order to help prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).
Device Description
Not Found
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K Number
K000147Device Name
CTC DVT-1 CALF GARMENT, MODEL DVT-1
Manufacturer
COMPRESSION THERAPY CONCEPTS, INC.
Date Cleared
2000-04-13
(86 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
COMPRESSION THERAPY CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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