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510(k) Data Aggregation
K Number
K113162Device Name
SLIDEWIRETM(TRADEMARK PENDING)
Manufacturer
Date Cleared
2012-07-20
(268 days)
Product Code
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
ACME-MONACO CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Acme Monaco Slidewire™ (Trademark Pending) is intended for use in diagnostic or interventional procedures to assist in directing a catheter to the desired anatomical locations in the coronary or peripheral vasculature.
Device Description
The Acme Monaco Hydrophilic Guidewire, hereafter referred to as Acme Monaco Slidewire®, is composed of a Nickel Titanium (aka NiTi or Nitinol) core wire, jacketed with a durable polymer that is receptive to a coating. The polymer resin is blended with Tungsten, a radiopaque metal and affixed to the core wire via adhesive. The jacketed core wire is then coated with a hydrophilic coating. The Acme Monaco Slidewire of can be constructed to various lengths, diameters and distal configurations, is a single-use device and provided sterile for commercial distribution.
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