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510(k) Data Aggregation
K Number
K251265Device Name
Resilience Fully Covered Esophageal Stent System
Manufacturer
Merit Medical Systems, Inc.
Date Cleared
2025-07-23
(90 days)
Product Code
ESW
Regulation Number
878.3610Why did this record match?
Applicant Name (Manufacturer) :
Merit Medical Systems, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K250909Device Name
Prelude Wave Hydrophilic Sheath Introducer
Manufacturer
Merit Medical Systems, Inc.
Date Cleared
2025-04-25
(30 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
Merit Medical Systems, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Merit Prelude Wave Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guidewires.
Device Description
The Prelude Wave™ Hydrophilic Sheath Introducer consists of a sheath introducer with compatible vessel dilator that snaps securely into the sheath introducer hub. The sheath hub contains an integral hemostasis valve. The sheath tubing is coated with a hydrophilic coating. A sidearm is affixed to the sheath hub and has a 3-way stopcock at its proximal end. The Prelude Wave™ Hydrophilic Sheath Introducer is available in 11cm and 23cm lengths, (French sizes 4F, 5F, 6F and 7F) and is designed to accept 0.018", 0.021" and 0.025" diameter guidewires. The Prelude Wave™ Hydrophilic Sheath Introducer is marketed with any of the following components, depending on the product configuration: guidewire, metal access needle, access needle with inner metal needle and outer plastic cannula and SnapFix™ securement device.
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K Number
K242229Device Name
Micro Ace Gold Advanced Micro Access System
Manufacturer
Merit Medical Systems, Inc.
Date Cleared
2025-01-15
(169 days)
Product Code
DRE
Regulation Number
870.1310Why did this record match?
Applicant Name (Manufacturer) :
Merit Medical Systems, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Merit Micro Ace™ Gold Advanced Micro Access System is intended for percutaneous placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guidewire into the vascular system.
Device Description
The Merit Micro Ace™ Gold Advanced Micro Access System (hereafter referred to as Micro Ace™ Gold) provides access to the vascular system and facilitates the placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guide wires. The system is available in 4 French and 5 French sizes – and includes the coaxial introducer-dilator pair, a 21 gauge needle and a 0.018” (0.46mm) guide wire.
The introducer-dilator assembly that is included in each kit is 10 cm effective length. The system will be offered with optional guidewires: Some catalog codes will include a nitinol wire with platinum guidewire tips; Some catalog codes will be offered with a stainless steel wire with platinum guidewire tips.
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K Number
K242873Device Name
Ventrax Delivery System
Manufacturer
Merit Medical Systems, Inc.
Date Cleared
2025-01-15
(114 days)
Product Code
DQY, DOY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Merit Medical Systems, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ventrax™ Delivery System is intended to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart.
Device Description
The Ventrax™ Delivery System is designed to provide a conduit to deliver diagnostic and therapeutic catheters to specific heart chambers and locations. It provides support for positioning and maintaining the position of catheters at specific locations in the heart. The sheath may be used for percutaneous entry. The system consists of four components: a sheath, a pigtail dilator, a straight dilator and a J-tipped Amplatz guidewire.
VENTRAX™ DELIVERY SYSTEM COMPONENTS
A. 8.5F Guiding Sheath Introducer: provides a conduit to deliver diagnostic and therapeutic catheters to specific heart chambers and locations. The sheath has an integrated valve to restrict blood loss, and a sideport for flushing and withdrawing blood.
B. Mating Pigtail Dilator: designed to conform to the sheath introducer inner diameter, has a tapered tip, has a pigtail at the distal end to assist aortic valve crossing, has an integrated valve to restrict blood loss, and has a sideport for flushing.
C. Mating Straight Dilator: designed to conform to the sheath introducer inner diameter and has a tapered tip. Usage of this straight dilator is optional. This straight dilator is intended to be used only when access is unsuccessful after using the mating pigtail dilator.
D. 0.035" X 220cm J-tipped Amplatz guidewire: provide path for sheath and dilator advancement.
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K Number
K241521Device Name
Prelude Small O.D. Introducer Guide Wire
Manufacturer
Merit Medical Systems, Inc.
Date Cleared
2024-12-10
(195 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
Merit Medical Systems, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Prelude Small O.D. Introducer Guide Wire is intended to facilitate the placement of introducer sheaths during diagnostic and interventional procedures.
The Prelude Small O.D. Introducer Guide Wire is indicated for use in the peripheral vasculature only.
Device Description
The Prelude® Small O.D. Introducer Guide Wire is composed of a stainless-steel core wire inside a stainless-steel coil. The guide wire is welded at the distal and proximal tips and has a polished weld finish. The stainless-steel construction provides radiopacity and visibility to the user under X-ray. The wires are available in outer diameters 0.018", 0.021" and 0.025", lengths from 45 cm to 80 cm, straight and double-ended J 3mm / straight tip shapes, Standard and Firm body wire stiffness profiles, with a flexible atraumatic tip.
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K Number
K233268Device Name
Impress Angiographic Catheter
Manufacturer
Merit Medical Systems, Inc.
Date Cleared
2024-05-22
(236 days)
Product Code
DQO
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
Merit Medical Systems, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Impress Angiographic Catheter is designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures. Angiographic catheters with marker bands may also be used for anatomical measurements.
Device Description
The Merit Impress Angiographic Catheters with/without hydrophilic coating are intravascular diagnostic catheters that are intended for the administration of contrast for conducting fluoroscopic studies. The catheters are available in a variety of 4F and 5F wire-braided and non-braided configurations ranging in length from 40cm to 125cm. The device may include a marker band to assist anatomical measurements. The devices are available in a variety of tip shapes to cater to variations in physician preference and patient anatomy.
The catheters consist of a shaft with a molded hub assembly. It is the shaft that may be offered with or without a wire-braided reinforcement. The distal tip of the device is tapered for efficient volume flow and dispersion of the contrast media. The distal tip is flexible so as to minimize the potential for vessel trauma.
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K Number
K240261Device Name
Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)
Manufacturer
Merit Medical Systems, Inc.
Date Cleared
2024-05-02
(92 days)
Product Code
KRD
Regulation Number
870.3300Why did this record match?
Applicant Name (Manufacturer) :
Merit Medical Systems, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Siege Vascular Plug is indicated for arterial embolization in the peripheral vasculature.
The Siege Vascular Plug is intended for therapeutic embolization to reduce or obstruct blood flow.
Device Description
The subject Siege Vascular Plug ("Device") is a self-expanding braided Nitinol vascular embolization implant that is supplied with components used for implantation. The Device has radiopaque marker bands attached to each end and a screw attachment for connection to the Delivery Wire. The Device is packaged collapsed within a Loader and attached to a 225 cm Delivery Wire that is provided within a hoop dispenser. The Delivery Wire has a lubricious, hydrophilic coating at its distal end (approximately 26.5cm long). A Tuohy Borst Valve is provided for flushing and maintaining hemostasis: a Torque Device is provided for releasing the Device; a Non-Vented Luer Cap is provided for device preparation.
The subject Siege Vascular Plug has been designed with a material, size, configuration, and shape that allows introduction through recommended 0.021" or 0.027" inner diameter commercial microcatheters for the embolization of arterial blood vessels in the peripheral vasculature. The Siege Vascular Plug Devices are provided in three different outer diameters (4.5 mm, 6.5 mm, 8.5 mm) to treat different artery diameter ranges (1.5 - 2.5 mm, 2.5 - 4 mm, 4 - 6 mm) in the peripheral vasculature.
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K Number
K233813Device Name
Bearing nsPVA Express
Manufacturer
Merit Medical Systems, Inc.
Date Cleared
2023-12-21
(21 days)
Product Code
NAJ, KRD
Regulation Number
870.3300Why did this record match?
Applicant Name (Manufacturer) :
Merit Medical Systems, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bearing nsPVA Particles are used for the embolization of peripheral hypervascularized tumors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs).
Do not use particles smaller than 355 microns for the treatment of leiomyoma uteri.
Device Description
Bearing nsPVA particles are irregularly-shaped, hydrophilic, non-resorbable particles made of 100% crosslinked poly(vinyl alcohol). These embolization particles are intended to provide vascular occlusion or reduction of blood flow within target vessels upon placement through a catheter.
The particles of the subject device, the Bearing nsPVA Express, are provided sterile and for single use in a 20 mL polycarbonate syringe with a luer-lock connector, individually packaged in a sterile foil peel pouch.
Bearing nsPVA particles are calibrated and available in 7 size ranges (see table below) to enable the physician to choose depending on the diameter of the vessel to be embolized. Each syringe contains 100 mg of Bearing nsPVA particles.
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K Number
K230418Device Name
Mighty Wire Guide Wire
Manufacturer
Merit Medical Systems, Inc.
Date Cleared
2023-10-28
(254 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
Merit Medical Systems, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Merit Mighty Wire is intended to be used to facilitate the placement of devices during diagnostic and interventional procedures in the central circulatory system, excluding the coronary arteries and neurovasculature.
Device Description
The wire is composed of a PTFE (polytetrafluoroethylene) coated stainless-steel core wire with a grind profile ending in a flexible distal tip. A PTFE coated stainless steel distal coil is laser-welded to the proximal end of the core wire grind profile and plasma arc-welded to the distal end of the core wire profile. The PTFE coating covers 100% of the guide wire surface. For wire lengths 230, 260, and 300cm, an additional radiopaque Platinum-Tungsten marker coil is welded to the core wire flexible distal tip. The distal tip is radiopaque.
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K Number
K232609Device Name
Micro Ace Advanced Micro Access System
Manufacturer
Merit Medical Systems, Inc.
Date Cleared
2023-09-27
(30 days)
Product Code
DRE
Regulation Number
870.1310Why did this record match?
Applicant Name (Manufacturer) :
Merit Medical Systems, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Micro Ace™ Advanced Micro Access System is intended for percutaneous placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guidewire into the vascular system.
Device Description
The Merit Micro Ace™ Advanced Micro Access System (hereafter referred to as Micro Ace™) provides access to the vascular system and facilitates the placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guide wire. The system is available in 4 French and 5 French sizes – and includes the coaxial introducer-dilator pair, a 21 gauge needle and a 0.018" (0.46mm) guide wire.
The introducer-dilator assembly that is included in each kit is 10 cm effective length. The system will be offered with optional guidewires:
• Some catalog codes will include a nitinol wire with platinum guide wire tips;
• Some catalog codes will be offered with a stainless steel wire with platinum guidewire tips.
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