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510(k) Data Aggregation
K Number
K122301Device Name
GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE
Manufacturer
VASCULAR SOLUTIONS ZERUSA LTD.
Date Cleared
2012-09-07
(37 days)
Product Code
DTL
Regulation Number
870.4290Why did this record match?
Applicant Name (Manufacturer) :
VASCULAR SOLUTIONS ZERUSA LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Guardian hemostasis valves are intended to maintain hemostasis during the use of diagnostic or interventional devices. Guardian hemostasis valves are indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8F (0.105" or 2.67 mm) during diagnostic/ interventional procedures.
The torque device is provided as an aid in steering the guidewire within the vascular anatomy.
Device Description
The Guardian hemostasis valves are designed to be used as conduits when interventional devices with diameters up to 8 F are inserted into the human vascular system. The devices have two seals: the lowpressure seal and the high-pressure seal. 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 allows for pressure injections up to 600 psi (40 ATM).
A guidewire introducer and guidewire torque device may be included with the Guardian II NC hemostasis valves.
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