NC TREK NEO™ Coronary Dilatation Catheter 3.50 mm x 20 mm / Rapid
NC TREK NEO™ - 1400350-20
Device Description
A flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has a double or triple-lumen, one for the guidewire and one or two for single- or double-balloon inflation; and 2) a rapid exchange (RX) type with a single-lumen. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. This is a single-use device.
Environmental Conditions
- Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place.
Device Sizes
- Balloon Diameter: 3.5000 Millimeter
- Balloon Length: 20.0000 Millimeter
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: LOX
Device Name: Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device Class: 2
Physical State: N/A
Definition: A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.5100
Third Party Flag: N
Medical Specialty: CV
Device IdentifiersDevice Id: 08717648232640
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A