(141 days)
GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guidewires and other interventional devices.
The GuideLiner is a catheter that consists of a single lumen distal tube (with a radiopaque marker band at the distal tip) secured to a proximal shaft. GuideLiner catheters are available in three sizes for use with 6F, 7F or 8F guide catheters. The catheters are packaged in a dispenser coil inside a single sterile barrier pouch and sterilized by ethylene oxide.
The provided text is a 510(k) summary for the GuideLiner catheter, a medical device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The document focuses on establishing substantial equivalence to a predicate device, device description, and intended use.
Therefore, I cannot extract the requested information as it 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).