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Found 14 results
510(k) Data Aggregation
K Number
K151877Device Name
MicroTract Access System
Manufacturer
ARSTASIS, INC.
Date Cleared
2015-08-07
(29 days)
Product Code
DRE
Regulation Number
870.1310Why did this record match?
Applicant Name (Manufacturer) :
ARSTASIS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MicroTract Access System is intended to allow the use of a .018" guidewire with a .035" or .038" guidewire compatible dilator up to 23cm in overall length.
Device Description
The MicroTract Access System contains a 20 gauge Access Needle, a 0.018" Guidewire, and a Dilator Adapter. The Dilator Adapter is a sterile, single use device that is hollow and has a tapered increase in outer diameter on one end. This shape allows the Adapter to fill the excess space between .018" guidewires and dilators with larger inner diameters.
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K Number
K140871Device Name
AXERA 2 ACCESS SYSTEM
Manufacturer
ARSTASIS, INC.
Date Cleared
2014-06-06
(63 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
ARSTASIS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
Device Description
The AXERA 2 is a device that is comprised of a Latchwire, anchor mechanism, shaft and handle with control features.
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K Number
K140287Device Name
AXERA RX ACCESS SYSTEM
Manufacturer
ARSTASIS, INC.
Date Cleared
2014-05-16
(100 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
ARSTASIS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
Device Description
The AXERA RX is a device that is comprised of a flexible tip, anchor mechanism, shaft and handle with control features.
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K Number
K140201Device Name
AXERA 2 ACCESS SYSTEM
Manufacturer
ARSTASIS, INC.
Date Cleared
2014-03-28
(60 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
ARSTASIS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
Device Description
The AXERA 2 is a device that is comprised of a Latchwire, anchor mechanism, shaft and handle with control features.
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K Number
K132263Device Name
AXERA 2 ACCESS SYSTEM
Manufacturer
ARSTASIS, INC.
Date Cleared
2013-08-19
(28 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
ARSTASIS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
Device Description
The AXERA 2 is a device that is comprised of a Latchwire, anchor mechanism, shaft and handle with control features.
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K Number
K123618Device Name
AXERA 2 ACCESS SYSTEM
Manufacturer
ARSTASIS, INC.
Date Cleared
2013-03-24
(121 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
ARSTASIS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
Device Description
The AXERA 2 is a device that is comprised of a latchwire, anchor mechanism, shaft and handle with control features.
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K Number
K123135Device Name
AXERA 2 ACCESS SYSTEM MODEL AXE200
Manufacturer
ARSTASIS, INC.
Date Cleared
2013-01-28
(115 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
ARSTASIS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
Device Description
The AXERA 2 is a device that is comprised of a latchwire, anchor mechanism, shaft and handle with control features.
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K Number
K121521Device Name
AXERA ACCESS SYSTEM
Manufacturer
ARSTASIS, INC.
Date Cleared
2012-06-21
(29 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
ARSTASIS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
Device Description
The AXERA is a device that is comprised of a latchwire, anchor mechanism, shaft and handle with control features.
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K Number
K113110Device Name
AXERA ACCESS SYSTEM
Manufacturer
ARSTASIS, INC.
Date Cleared
2011-11-09
(20 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
ARSTASIS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. The System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
Device Description
The AXERA is a device that is comprised of a latchwire, anchor mechanism, shaft and handle with control features.
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K Number
K103421Device Name
ARSTASIS DILATOR ADAPTER
Manufacturer
ARSTASIS, INC.
Date Cleared
2011-05-24
(183 days)
Product Code
DRE
Regulation Number
870.1310Why did this record match?
Applicant Name (Manufacturer) :
ARSTASIS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Adapter is intended to allow the use of a .018" guidewire with a .035" or .038" guidewire compatible dilator up to 23cm in overall length.
The Adapter is intended to allow the use of a .018" guidewire with a 0.035" or 0.038" guidewire compatible dilator up to 23 cm in overall length and to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
Device Description
The Adapter is a sterile, single use device that is hollow and has a tapered increase in outer diameter on one end. This shape allows the Adapter to fill the excess space between .018" guidewires and dilators with larger inner diameters.
The Dilator Adapter is a polyethylene bump extrusion that fits into a .035"-.038" compatible vessel dilator with an internal diameter-sized-- to an .018" guidewire.
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