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510(k) Data Aggregation
K Number
K162565Device Name
VIA 17 Microcatheter
Manufacturer
SEQUENT MEDICAL, INC.
Date Cleared
2017-02-18
(157 days)
Product Code
DQY, KRA
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
SEQUENT MEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VIA™ 17 Microcatheter is intended for the introduction of non-liquid interventional devices (such as coils/ stents) and infusion of diagnostic agents (such as contrast media) into the neuro, peripheral and coronary vasculature.
Device Description
The VIA™ 17 Microcatheter is a sterile single lumen device designed to aid the physician in accessing distal vasculature when used with a guide catheter and steerable guidewire. Variable shaft stiffness ranging from a flexible tip to a semi-rigid proximal section aid the physician in tracking over selectively placed guidewires. The proximal end of the catheter incorporates a standard luer adapter to facilitate attachment of accessories. A single radiopaque marker positioned at the distal tip facilitates fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating which reduces friction during manipulation in the vessel. The inner lumen of the catheter has a PTFE liner which assists with delivery of interventional devices, such as coils/stents. The VIATM 17 Microcatheter is available in an effective length of 154 cm and an inner diameter of 0.0175 inches. The VIA™ 17 Microcatheter is presented in a tyvek pouch and is sterile, single use only and non-pyrogenic. Accessories: Each VIA™ 17 Microcatheter is provided with shaping mandrels to facilitate distal tip shaping. In intravascular procedures, the device assists the physician in: - Accessing the targeted vasculature to facilitate the delivery of interventional devices, such as coils and stents, and infusion of diagnostic agents such as contrast.
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K Number
K150894Device Name
VIA 21 Microcatheter
Manufacturer
SEQUENT MEDICAL, INC
Date Cleared
2015-08-28
(148 days)
Product Code
DQY, KRA
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
SEQUENT MEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VIA™ 21 Microcatheter is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or non-liquid therapeutic agents into the neuro, peripheral, and coronary vasculature.
Device Description
The VIA™ 21 Microcatheter is designed to be introduced over a steerable guidewire into the vasculature. The physician inserts the catheter into the vein or artery through the skin (percutaneous) using a sheath or guidewire. The device can then be navigated to the treatment site. Navigation is aided by the coated surface of the catheter which assists with manipulation while in the vasculature. Throughout the physician can obtain the position of the catheter by the tip marker using fluoroscopic techniques. Diagnostic, therapeutic and interventional devices can be delivered through the lumen of the catheter to the treatment site.
The VIATM 21 Microcatheter is a sterile single lumen device designed to aid the physician in accessing distal vasculature when used with a guide catheter and steerable guidewire. Variable shaft stiffness ranging from a flexible tip to a semi-rigid proximal section aid the physician in tracking over selectively placed guidewires. The proximal end of the catheter incorporates a standard luer adapter to facilitate attachment of accessories. A single radiopaque marker positioned at the distal tip facilitates fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating which reduces friction during manipulation in the vessel. The inner lumen of the catheter has a PTFE liner which assists with delivery of interventional devices, such as an intraluminal flow diverter.
The VIA™ 21 Microcatheter is available in an effective length of 154 cm and an inner diameter of 0.021 inches.
The VIA™ 21 Microcatheter is presented in a tyvek pouch and is sterile, single use only and non-pyrogenic.
Accessories: Each VIA™ 21 Microcatheter is provided with a shaping mandrel to facilitate distal tip shaping.
In intravascular procedures, the device assists the physician in:
- Accessing the targeted vasculature to facilitate the delivery of interventional devices, such as intraluminal flow diverters, infusion of diagnostic agents such as contrast and infusion of therapeutic agents.
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K Number
K132652Device Name
VIA MICROCATHETER, VIA PLUS MICROCATHETER
Manufacturer
SEQUENT MEDICAL, INC
Date Cleared
2013-12-20
(116 days)
Product Code
DQY, KRA
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
SEQUENT MEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VIA™ Microcatheter is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media), or therapeutic agents into the neuro, peripheral and coronary vasculature.
Device Description
The VIA™ Microcatheter and VIA™ PLUS Microcatheter are designed to be introduced over a stcerable guidewire into the vasculature. The physician inserts the catheter into the vein or artery through the skin (percutaneous) using a sheath or guidewire. The device can then be navigated to the treatment site. Navigation is aided by the coated surface of the catheter which assists with manipulation while in the vasculature. Throughout the procedure the physician can obtain the position of the catheter by the tip marker using fluoroscopic techniques. Interventional devices and infusion of diagnostic and therapeutic agents can be delivered through the lumen of the catheter to the treatment site.
The VIA™ Microcatheter is a sterile single lumen device with a single distal tip marker designed to aid the physician in accessing distal vasculature when used with a guide catheter and steerable guidewire. Variable shaft stiffness ranging from a flexible tip to a semi-rigid proximal section aid the physician in tracking over selectively placed guidewires. The proximal end of the catheter incorporates a standard luer adapter to facilitate attachment of accessories. A single radiopaque marker positioned at the distal tip facilitates fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating which reduces friction during manipulation in the vessel. The inner lumen of the catheter has a PTFE liner which assists with delivery of interventional devices, such as an intraluminal flow diverter.
The VIA™ and VIA™ PLUS Microcatheter are available in effective lengths of 154 cm and 133 cm and inner diameters of 0.27 inches and 0.33 inches, respectively. For commercialization purposes the 0.027 inch diameter will be named the VIA™ Microcatheter and the 0.033 inch diameter will be named the VIA™ PLUS Microcatheter.
The VIA™ Microcatheter is presented in a tyvek pouch and is sterile, single-use only and nonpvrogenic.
Accessories: Each VIA™ Microcatheter is provided with a shaping mandrel to facilitate distal tip shaping.
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K Number
K123477Device Name
VIA MICROCATHETER, VIA PLUS MICROCATHETER
Manufacturer
SEQUENT MEDICAL, INC
Date Cleared
2013-03-19
(126 days)
Product Code
KRA, DQY
Regulation Number
870.1210Why did this record match?
Applicant Name (Manufacturer) :
SEQUENT MEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VIATM Microcatheter is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the peripheral and coronary vasculature.
Device Description
The VIA™ Microcatheter and VIA™ PLUS Microcatheter are designed to be introduced over a steerable guidewire into the vasculature. The physician inserts the catheter into the vein or artery through the skin (percutaneous) using a sheath or guidewire. The device can then be navigated to the treatment site. Navigation is aided by the coated surface of the catheter which assists with manipulation while in the vasculature. Throughout the procedure the physician can obtain the position of the catheter by the tip marker using fluoroscopic techniques. Diagnostic, therapeutic and interventional devices can be delivered through the lumen of the catheter to the treatment site.
The VIA™ Microcatheter is a sterile single lumen device with one distal tip marker designed to aid the physician in accessing distal vasculature when used with a guide catheter and steerable guidewire. Variable shaft stiffness ranging from a flexible tip to a semi-rigid proximal section aid the physician in tracking over selectively placed guidewires. The proximal end of the catheter incorporates a standard luer adapter to facilitate attachment of accessories. A single radiopaque marker positioned at the distal tip facilitates fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating which reduces friction during manipulation in the vessel. The inner lumen of the catheter has a PTFE liner which assists with delivery of interventional devices, such as an intraluminal flow diverter.
The VIA™ and VIA™ PLUS Microcatheter is available in effective lengths of 154 cm and 133 cm and inner diameters of 0.27 inches and 0.33 inches respectively. For commercialization purposes the 0.027 inch diameter will be named the VIATM Microcatheter and the 0.033 inch diameter will be named the VIA™ PLUS Microcatheter.
The VIA™ Microcatheter is presented in a tyvek pouch and is sterile, single use only and non-pyrogenic.
Accessories: Each VIA™ Microcatheter is provided with a shaping mandrel to facilitate distal tip shaping.
In intravascular procedures, the device assists the physician in:
- . Accessing the targeted vasculature to facilitate the delivery of interventional devices, such as intraluminal flow diverters, infusion of diagnostic agents such as , contrast and infusion of therapeutic agents.
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