(37 days)
The Vector " Thi PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arterio-venous dialysis fistulae.
The Vector Catheter is not indicated for use in the coronary arteries or for placement of or post dilatation of stents
The Vector" PTA Catheter is a high pressure, non-compliant balloon catheter with a radiopaque coating on the balloon. The radio-opaque coating on the working length of the balloon minimizes or eliminates the need for using contrast solution to inflate the balloon. The radioopaque coating delineates the working length of the balloon and provides continuous fluoroscopic visibility during balloon placement. Saline may be used to inflate the balloon without affecting visualization. Contrast mixture may be used at the discretion of the physician.
The Vector4™ PTA Balloon Dilatation Catheter is a coaxial dual lumen over-the-wire balloon dilatation catheter. The central lumen accommodates guide wires up to 0.035 inches in diameter while the outer lumen is the inflation lumen for the balloon. The catheter includes an atraumatic tip to ease advancement of the catheter to and through the stenosis. The distal tip is visible under fluoroscopy.
The balloon is a high pressure composite balloon with a radiopaque coating on the working length to help visualize placement within the lesion during both placement and inflation without the use of contrast. The balloon's rated burst pressure is 30 atm.
The catheter is supplied sterile and non-pyrogenic. Different balloon sizes (5 mm to 10 mm) and catheter lengths (50 to 135 cm) are available. The proximal end of the catheter contains a hub with two female luer locks.
The device is compatible with 6-7F introducers. The introducer compatibility for each device size is listed on the device label itself. The materials used in the construction are biocompatible and latex free.
Here's a breakdown of the acceptance criteria and the study information for the Vector™ PTA Balloon Dilatation Catheter, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Balloon rated burst pressure | Met specifications |
| Balloon compliance | Met specifications |
| Critical dimension verifications | Met specifications |
| Guidewire and introducer compatibility | Met specifications |
| Fluoroscopic visualization | Met specifications (comparable to predicate device, allowing visualization without contrast) |
| Inflation/deflation times | Met specifications |
| Repeat inflation | Met specifications |
| Leak | Met specifications |
| Tensile | Met specifications |
| Kink | Met specifications |
| Torque | Met specifications |
| Corrosion | Met specifications |
| Luer lock compatibility | Met specifications |
| Coating integrity | Met specifications |
| Distribution | Met specifications |
| Biocompatibility (ISO 10993-1 for short duration contact with blood ( |
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).