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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.

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