(28 days)
The Pheron PTA balloon catheter is indicated to dilate stenosis in the renal, iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Pheron Percutaneous Transluminal Angioplasty (PTA) balloon catheter is indication of stendlic seqments in peripheral vessels. The dilatation balloon is designed to inflate to a known diameter at a specific inflation pressure consistent with the compliance chart on the label. Two radiopaque markers are located at either end of the ballitate fluoroscopic visualization and positioning of the balloon catheter towards and across the lesion. The balloon catheter includes a tapered soft tip to facilitate advancement of the catheter.
The balloon catheter shaft has two Luer ports at the proximal end. One port (inflation port) serves for connecting an inflation device to inflate/deflate the balloon. The other port enables insertion of the guide wire lumen. The balloon catheter is a dual lumen design, with both lumens contained within one tube. The smaller lumen is the balloon inflation lumen, as described above. The larger lumen permits the use of guide wires with a maximum diameter of 0.035" to facilitate advancement of the balloon catheter towards and through the lesion(s) to be dilated. The balloon catheter is compatible with introducer sheath (introducer) sizes according to the recommendations on the label. The balloon catheter has a BIOC (silicone) coating to improve the trackability characteristics.
The provided text is a 510(k) premarket notification for the Pheron Peripheral PTA Catheter. It describes the device, its intended use, and states that it is substantially equivalent to a predicate device. However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, data provenance, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.
§ 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).