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510(k) Data Aggregation
K Number
K101113Device Name
GUARDIAN II NC HEMOSTASIS VALVE
Manufacturer
ZERUSA LIMITED
Date Cleared
2010-05-21
(30 days)
Product Code
DTL
Regulation Number
870.4290Why did this record match?
Applicant Name (Manufacturer) :
ZERUSA LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Guardian® II NC HV is intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures.
The guidewire introducer is included to facilitate the guidewire's passage through the Guardian® II NC HV.
The Torque Device is included to manipulate the steering of the guidewire within the vascular regions.
Device Description
The Zerusa Guardian® II NC Hemostasis Valve is designed to be used as a conduit when interventional devices with diameters up to 8.0F (2.67mm or 0.105") are inserted into the human vascular system.
The device has two seals: the low-pressure seal (or wiper seal) and the high-pressure seal. Depressing the cap opens the low-pressure seal, releasing the cap closes the seal. The high-pressure seal is operated by rotating the nut clockwise. Closure of the highpressure seal, which is achieved when the nut can no longer rotate, secures the diagnostic/interventional device in position within the vasculature and also allows for pressure injections up to 150 psi (10 ATM).
Included with the Guardian® II NC Hemostasis Valve is a Guidewire Introducer, which is used to facilitate entry of the guidewire into the Guardian® II NC Hemostasis Valve. It consists of an austenitic stainless steel tube connected to a hub constructed of polycarbonate.
Also included with the Guardian® II NC HV is a simple Guidewire Torquer which is used to manipulate the steering of a guidewire within the vascular regions.
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K Number
K092711Device Name
GUARDIAN II HEMOSTASIS VALVE
Manufacturer
ZERUSA LIMITED
Date Cleared
2009-10-01
(28 days)
Product Code
DTL
Regulation Number
870.4290Why did this record match?
Applicant Name (Manufacturer) :
ZERUSA LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Guardian™ II HV is intended to maintain hemostasis during the use of diagnostic/interventional device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures.
The guidewire introducer is included to facilitate the guidewire's passage through the Guardian™ II HV.
The Torque Device is included to manipulate the steering of the guidewire within the vascular regions.
Device Description
The Zerusa Guardian™ II Hemostasis Valve is designed to be used as a conduit when interventional devices with diameters up to 8.0F (2.67mm or 0.105") are inserted into the human vascular system.
The device has two seals: the low-pressure seal (or wiper seal) and the highpressure seal. Depressing the cap engages the Quikloc " to open the low-pressure seal, depressing the cap again closes the seal. The high-pressure seal is operated by rotating the nut clockwise. Closure of the high-pressure seal, which is achieved when the nut can no longer rotate, secures the diagnostic/interventional device in position within the vasculature and also allows for pressure injections up to 150 psi (10 ATM).
Included with the Guardian™ II Hemostasis Valve is a Guidewire Introducer, which is used to facilitate entry of the guidewire into the Guardian IIM II Hemostasis Valve. It consists of an austenitic stainless steel tube connected to a hub constructed of polycarbonate.
Also included with the Guardian™ II HV is a simple Guidewire Torquer which is used to manipulate the steering of a guidewire within the vascular regions.
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K Number
K073620Device Name
GUARDIAN HEMOSTASIS VALVE
Manufacturer
ZERUSA LIMITED
Date Cleared
2008-02-27
(63 days)
Product Code
DTL
Regulation Number
870.4290Why did this record match?
Applicant Name (Manufacturer) :
ZERUSA LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Guardian Hemostasis Valve is intended to maintain hemostasis during the introduction, withdrawal and use of diagnostic/interventional devices during vascular procedures. The Guardian HV is intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures. The guidewire introducer is included to facilitate the guidewire's passage through the Guardian HV. The Torque Device is intended to manipulate the steering of the guidewire within the vascular regions.
Device Description
The Zerusa Guardian™ Hemostasis Valve is designed to be used as a conduit for which interventional devices with diameters up to 8.0F are inserted into the human vascular system. The device has two seals: the low-pressure seal and the high-pressure seal. Depressing the cap engages the Quikloc TM to open the low-pressure seal, depressing the cap again closes the seal. The high-pressure seal is operated by rotating the nut clockwise. Closure of the high-pressure seal secures the diagnostic/interventional device in position within the vasculature and also allows for pressure injections. The two independently operated seals allow for minimal blood loss during vascular procedures. When the low pressure seal is open, it allows the device to be flushed. During the procedure, the low pressure seal is opened in order to allow the advancement/withdrawal of diagnostic/interventional devices. Included with the Guardian™ Hemostasis Valve is a Guidewire Introducer, which is used to facilitate entry of the guidewire into the hemostasis valve. The Guidewire Introducer has an effective length of 125mm (4.9") and an inside diameter of 0.6mm (or 0.023"). A Guidewire Torquer, intended to manipulate the steering of the guidewire within the vascular regions, is also included.
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K Number
K052381Device Name
GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER
Manufacturer
ZERUSA LIMITED
Date Cleared
2005-11-21
(83 days)
Product Code
DTL
Regulation Number
870.4290Why did this record match?
Applicant Name (Manufacturer) :
ZERUSA LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Guardian HV is intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures. The guidewire introducer is included to facilitate the guidewire's passage through the Guardian HV.
Device Description
The Zerusa Guardian™ Hemostasis Valve is designed to be used as a conduit for which interventional devices with diameters up to 8.0F are inserted into the human vascular system. The device has two seals: the low-pressure seal and the high-pressure seal. Depressing the cap engages the Quikloc TM to open the low-pressure seal, depressing the cap again closes the seal. The high-pressure seal is operated by rotating the nut clockwise. Closure of the high-pressure seal secures the diagnostic/interventional device in position within the vasculature and also allows for pressure injections. The two independently operated seals allow for minimal blood loss during vascular procedures. When the low pressure seal is open, it allows the device to be flushed. During the procedure, the low pressure seal is opened in order to allow the advancement/withdrawal of diagnostic/interventional devices. Included with the Guardian™ Hemostasis Valve is a Guidewire Introducer, which is used to facilitate entry of the guidewire into the hemostasis valve. The Guidewire Introducer has an effective length of 125mm (4.9") and an inside diameter of 0.6mm (or 0.023").
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