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510(k) Data Aggregation
K Number
K193194Device Name
CrossTorq 14 Guidewire
Manufacturer
Date Cleared
2019-12-13
(24 days)
Product Code
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
Scientia Cardio Access LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CrossTorqTM 14 Guidewire is intended for general vascular use within the coronary and peripheral vasculatures to introduce and position catheters and other interventional devices. The CrossTorqTM 14 Guidewire is not intended for use in the neurovasculature.
Device Description
Scientia Cardio Access's CrossTorg™ 14 Guidewire is a 0.014" diameter steerable guidewire with a shapeable tip to aid in accessing vasculature. The guidewire is supplied sterile and is for single use only. It is provided with the 4 different tip loads, or tip stiffnesses: 1 gram. 10 gram, and 15 gram. These tip stiffnesses are referred to as Soft, Standard, Support, and Extra Support. respectively. The product is offered in lengths of 200cm and 300cm.
The distal portion of the guidewire tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The guidewire has a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in vessels.
The guidewire is provided with a shaping mandrel (to shape the flexible tip of the guidewire), an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve) and a torque device (to attach to the proximal portion to facilitate gripping and manipulation of the guidewire during use). The shaping mandrel, introducer and torque accessory devices are included to facilitate use of the guidewire and are not intended to contact the patient's body.
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