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510(k) Data Aggregation
K Number
K153494Device Name
HQS Introducer (Model 2064-HQS)
Manufacturer
Date Cleared
2016-08-25
(265 days)
Product Code
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
ALSEAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
HQS Introducer (Model 2064-HQS) is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.
Device Description
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K Number
K133296Device Name
XCATH
Manufacturer
Date Cleared
2014-02-14
(112 days)
Product Code
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
ALSEAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
XCath (model 2064-XC) is intended to be inserted into the HQS Introducer (model 2064-HQS) to establish multiple and simultaneous conduits through the same vascular access (previously established by the HQS introducer).
The whole XCath / HQS allows insertion of several endovascular devices at the same time while minimizing blood loss associated with such insertions.
Device Description
The XCath (model 2064-XC) consists of a multiple ways access (2, 3 or 4 ways) adapted to the HQS Introducer (K113849) to optimize the sealing when several vascular tools up to 9,3F need to be introduced through the same vascular access.
The device features include (1) a flexible multilumen body, with 2, 3 or 4 channels compatible with the open valve of HQS Introducer; (2) a base with 2, 3 or 4 valves, (3) Extension line for each valve with stopcock and Luer Lock connection.
Once the XCath is connected to the HQS Introducer, the device can accommodate vascular tools up to 9,3 French (3,1mm). The XCath (accessory) is fixed in proximal position of the HQS introducer body and allows the simultaneous insertion of several vascular tools.
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K Number
K113849Device Name
HQS INTRODUCER
Manufacturer
Date Cleared
2012-07-31
(215 days)
Product Code
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
ALSEAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The HQS introducer (Model 2064-HQS) is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions
Device Description
The High Quality Sealing (HQS) Introducer comprises 4 elements, a radio- opaque introducer sheath equipped with a haemostasis valve, a radio- opaque dilator, a centering wire device and an extension line with 3 ways stopcock. The range of HQS introducer (18F, 20F, 22F, 24F, 26F) permits the insertion, preserving sealing, of large caliber tools, from OF, up to the nominal size of-the-introducer-sheath.. The introducer and its adjustable valve are easily handled with one hand. The distal tip is designed to perform an efficient introduction of the HQS introducer with the dilator in the vessel. The centering device permits to introduce a guidewire through the valve and to keep a perfect sealing. The extension line is connected to the lateral port of the introducer for the injection during the procedure.
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