(74 days)
The Cordis Mega PTA Balloon Catheters are designed for dilatation of stenotic lesions within the peripheral vessels.
Mega catheters have a coaxial design (tube within a tube) with a balloon on the distal tip. Two (2) lumens, an inner and outer lumen, are split on the proximal end by a Y-shaped one piece hub. The inner lumen (denoted by "thru") molded into the hub) is used for contrast medium or saline injections and guidewire insertion (maximum guidewire diameter is 0.018"). The outer lumen (denoted by "balloon" molded into the hub) is used for inflation and deflation of the balloon. Two (2) radiopaque marker bands placed within the balloon working length aid the physician in proper balloon placement.
The provided text is a summary of substantial equivalence for a medical device (Cordis Mega PTA Balloon Catheter) and does not contain any information about acceptance criteria or a study proving device performance against such criteria. The document is a K95 submission (a premarket notification for a Class II medical device) and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria through a clinical study involving AI or human readers.
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§ 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).