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510(k) Data Aggregation
K Number
K143252Device Name
Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange)
Manufacturer
NEEDLETECH PRODUCTS, INC.
Date Cleared
2015-04-23
(161 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
NEEDLETECH PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The QuikTork guide wire torque device is intended to facilitate guide wire interventional procedures.
Device Description
The QuikTork torque device is designed and intended to be used for the manipulation and placement of guide wires used during interventional procedures. The QuikTork device is not body contacting as the device is used by threading the guide wire end, which is outside the body, through the device lumen to provide an easier grip for manipulation of the guide wire. Once the guide wire is positioned, the QuikTork is removed. The device consists of one piece of molded polyoxymethylene, and is yellow or orange depending on the diameter of the guide wire that will be used with the device. The yellow device supports guide wire diameters 0.010 to 0.020 inches, and the orange device supports guide wire diameters 0.025 to 0.040 inches.
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K Number
K100665Device Name
MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX
Manufacturer
NEEDLETECH PRODUCTS, INC.
Date Cleared
2010-06-24
(108 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
NEEDLETECH PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MARROWMAX Bone Marrow Aspiration Needle is a stylet/cannula system to be used to obtain bone marrow and/or autologous blood from patients intraoperatively by use of a syringe.
Device Description
MARROWMAX Bone Marrow Aspiration Needle Kit
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K Number
K031173Device Name
NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013
Manufacturer
NEEDLETECH PRODUCTS, INC.
Date Cleared
2003-07-23
(100 days)
Product Code
GDF
Regulation Number
878.4800Why did this record match?
Applicant Name (Manufacturer) :
NEEDLETECH PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The guidewire introducer needles are intended for use as introducers/cannula for percutaneous introduction and placement of guidewires in vascular procedures.
Device Description
The NeedleTech Guidewire Introducer Needle consists of a stainless steel cannula with an attached plastic luer lock hub on one end and a ground point or blunt tip on the other end. The device is intended to be supplied non-sterile and packaged in bulk.
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