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510(k) Data Aggregation
K Number
K152497Device Name
PW Guidewires
Manufacturer
Date Cleared
2016-01-22
(143 days)
Product Code
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
TATARA VASCULAR, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PW Guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PCTA) and percutaneous transluminal angioplasty (PTA). The PW Guidewires are not to be used in cerebral blood vessels.
Device Description
The Tatara Vascular, LLC PW Guidewires are steerable guidewires with a maximum diameter of 0.014" (0.36mm) and nominal length of 180cm. The wires are constructed from a stainless steel solid core wire with two grind profiles that distinguish the gram stiffness of the wire. The core wire transitions to an angled tip of either 0.30mm or 0.75 mm in length. The distal end of the guidewires have a radiopaque coil. A hydrophilic coating is applied to the distal portion of the guidewires. The proximal portion of the guidewires is coated with polytetrafluoroethylene (PTFE).
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