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510(k) Data Aggregation
K Number
K232662Device Name
BNLE Hydrophilic Jacketed Peripheral Guidewire
Manufacturer
Biomerics NLE
Date Cleared
2024-05-14
(257 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
Biomerics NLE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BNLE Hydrophilic Jacketed Peripheral Guidewires are intended to direct a catheter to a desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.
Device Description
The BNLE Hydrophilic Jacketed Peripheral Guidewire is available in 150 cm - 260 cm lengths and in 0.018" - 0.035" diameter ranges. The hydrophilic coated guidewire consists of a nickel-titanium alloy core wire and tungsten infused polyurethane jacket in configurations of wire stiffness and tip shape. The finished guidewire is placed in a dispenser hoop and Tyvek pouch. Five (5) Tyvek pouches are placed into a shelf box with an IFU, and 26 shelf cartons are placed into a shipper box. Labels are placed on the Tyvek pouch and shelf box. The finished product is EO sterilized.
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K Number
K221390Device Name
BNLE Access Guidewire
Manufacturer
Biomerics NLE
Date Cleared
2023-04-28
(350 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
Biomerics NLE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BNLE Access Guidewire is intended for percutaneous entry of peripheral vessels using the Seldinger Technique. This device is not intended for use in the coronary or cerebral vasculature.
Device Description
The BNLE Access Guidewires are available in 40 cm to 80 cm lengths and in the 0.018" – 0.021" diameter range. The BNLE Access Guidewires are available with Nitinol or Stainless Steel (SS) shafts and in configurations with SS coils or radiopaque Tungsten coils.
The BNLE Access Guidewires consist of a solid core shaft with a ground tapered section at the distal end of the guidewire. A micro-coil is wound with a lumen that is then placed over the tapered distal section. The distal end is secured to the shaft via a weld and the proximal end is bonded to the shaft using adhesive. The micro-coil will provide tip radiopacity in designated models. The finished guidewire is placed in a protective polymer dispenser hoop for either sterile packaging in a labeled Tyvek pouch or shipped in bulk non-sterile condition to use with in a procedure tray by a customer.
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