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510(k) Data Aggregation
K Number
K231468Device Name
SCOUT MD Surgical Guidance System
Manufacturer
Merit Medical System, Inc.
Date Cleared
2024-02-12
(266 days)
Product Code
NEU
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
Merit Medical System, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SCOUT MD Reflector is intended to be placed percutaneously in soft tissue (>30 days) to mark a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (SCOUT MD System) the SCOUT MD Reflector is located and surgically removed with the target tissue. The SCOUT MD System is intended only for the non-imaging detection and localization of the SCOUT MD Reflector that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.
Device Description
The SCOUT MD Delivery System is used to implant the preassembled SCOUT MD Reflector. The needle of the Delivery System is percutaneously advanced into tissue to the site to be marked for biopsy or surgical removal. Needle placement is confirmed under imaging technique (radiographic, ultrasound). The Reflector (tissue marker) is deployed at the target site and the Delivery Device is removed from the patient and discarded. The Reflector, a passive implant, remains in situ and, if surgical removal of the target tissue is necessary, the Reflector is located at the time of surgery (intraoperatively) by the SCOUT MD Surgical Guidance System. The SCOUT MD Guide/Handpiece connected to the SCOUT MD Console is used to detect the SCOUT MD Reflector but it does not contact tissue. SCOUT MD Guides are always used while inside the SCOUT Guide Sheath. When the SCOUT MD System detects the Reflector, the Console emits audible feedback that increases in cadence as the Guide is placed closer to the Reflector. The distance between the distal end of the Guide and the detected Reflector, in millimeters, is displayed on the Console. If necessary, the Reflector is removed from the patient during a subsequent surgical procedure along with the tissue of interest or the Reflector can be left in-situ.
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K Number
K230636Device Name
Maestro Microcatheter
Manufacturer
Merit Medical System, Inc.
Date Cleared
2023-03-30
(23 days)
Product Code
KRA
Regulation Number
870.1210Why did this record match?
Applicant Name (Manufacturer) :
Merit Medical System, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels. The catheter should not be used in the cerebral vessels.
Device Description
The Maestro Microcatheter is available in working length sizes 110cm, 130cm, 150cm, 165cm and 175cm lengths. The distal tip of the microcatheter is offered in straight or pre-shaped 45 degree and swan neck configurations. The proximal end of the catheter consists of a molded winged hub with a tapered strain relief. The outer surface of the distal 80cm of the microcatheter shaft is coated with a hydrophilic coating designed to facilitate the introduction of the catheter into the vasculature. The microcatheter incorporates a radiopaque marker at the distal tip to facilitate fluoroscopic visualization. The Maestro Microcatheter is offered with two 3ml syringes.
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K Number
K212817Device Name
Merit Siege Vascular Plug
Manufacturer
Merit Medical System, Inc.
Date Cleared
2021-12-15
(103 days)
Product Code
KRD
Regulation Number
870.3300Why did this record match?
Applicant Name (Manufacturer) :
Merit Medical System, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Siege Vascular Plug is indicated for arterial embolization in the peripheral vasculature.
Device Description
The Siege™ Vascular Plug (“Device”) is a self-expanding braided nitinol vascular occlusion 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 a Delivery Wire. The Device is packaged collapsed within a Loader and attached to a 180cm Delivery Wire that is provided within a hoop dispenser. Touhy Borst Valves are provided for flushing and maintaining hemostasis. A Torque Device is provided for releasing the Device.
The Siege™ Vascular Plug has been designed with a material, size, configuration and shape that allows introduction through recommended 0.027" inner diameter commercial microcatheters for the occlusion of blood vessels in the peripheral vasculature. The Siege™ Vascular Plug Devices are provided in four different diameters (3mm, 4mm, 5mm, 6mm) to treat different sized blood vessels in the peripheral vasculature. The Siege™ Vascular Plug is designed to be used under fluoroscopy for delivery and implantation in the peripheral vasculature. The main users of the device are physicians trained in vascular embolization.
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K Number
K193571Device Name
Go2Wire Guide Wire
Manufacturer
Merit Medical System, Inc.
Date Cleared
2020-04-08
(107 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
Merit Medical System, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Merit GO2WIRE™ is intended to facilitate the placement and exchange of devices during peripheral diagnostic and interventional procedures.
Device Description
The Merit Go2Wire guide wire will consist of 0.035" guide wire configurations available in 145, 175, 210, 260, and 300cm. The distal tip flex configurations are Floppy, Standard and Intermediate (Modified J). The distal tip shapes are either straight or modified J.
The wire is composed of a stainless-steel core wire, a PTFE coated coil, a white PTFE sleeve, a platinum-tungsten marker coil, and an optional extension system connector. The wire's proximal end is covered by a white PTFE sleeve that terminates at 100cm from the distal tip. The distal 100 cm of the wire is covered with a green PTFE pre-coated coil. The PTFE coated coil and platinum-tungsten coil are welded to the core on the very distal tip. The distal tip is shapeable and radiopaque. A torque device is included to facilitate wire steering within the vascular anatomy.
An 0.035" extension wire consisting of PTFE coated stainless steel 155cm in length to extend the length of the wire to allow initial usage with a short wire and then extendable to allow catheter exchanges when required.
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