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The PRONTO extraction catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

The SKYWAY support catheter is intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The SKY WAY OTW also may be used to subselectively infuse/deliver therapeutic agents.

The TWIN-PASS dual access catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.

The Pronto V3 extraction catheter is a dual lumen, hydrophilically coated, rapid exchange catheter with related accessories. The smaller wire lumen of the catheter is able to accommodate guidewires that are <= 0.014"/0.36mm in diameter. The larger extraction lumen allows for the removal of thrombus by use of the included syringe through the extension line and stopcock. The catheter has a rounded distal tip with a protected, sloped opening of the extraction lumen to facilitate advancement of the catheter into the blood vessel and maximize extraction of thrombus through the extraction lumen. The proximal end of the catheter has a standard luer adapter that attaches to the included extension line, stopcock and syringes. The catheter has a working length of 140cm and is compatible with standard 6F guide catheters. A 70um filter basket is included for assistance in filtering the blood removed during the procedure for laboratory analysis of any thrombosis.

The Pronto LP extraction catheter is a dual lumen, hydrophilically coated rapid exchange catheter with related accessories. The smaller wire lumen of the catheter is able to accommodate guidewires that are <0.014"/0.36mm in diameter. The larger extraction lumen comes pre-loaded with a stylet that resists kinking during delivery but is removed to allow for the removal of thrombus by aspiration. The catheter has a rounded distal tip with a protected, sloped opening of the extraction lumen to facilitate advancement of the catheter into the blood vessel and maximize extraction of thrombus the extraction lumen. The proximal end of the catheter has a Yadapter hub containing a self-sealing stylet port, as well as a side-port for the attachment of the included extension line. The catheter has a working length of 137cm and is compatible with standard 6F guide catheters. A 70um filter basket is included for assistance in filtering the blood removed during the procedure for laboratory analysis of any thrombosis.

The Skyway OTW (over-the-wire) and Skyway RX (rapid exchange) support catheters are single lumen, hydrophilically coated catheters designed for use in the arterial vasculature. The catheters provide support for 0.014"/0.36mm guidewires during interventional procedures, and allow for the exchange of one distally located guidewire for another one while maintaining access to distal vasculature. The Skyway RX has a rapid exchange port that allows for the insertion of the catheter over a short guidewire; a stiffening mandrel provides support and pushability during catheter insertion.

The Twin-Pass dual access catheter is a hydrophilically coated, dual lumen catheter designed for use in the arterial vasculature. The catheter provides support for 0.014"/0.36mm guidewires during interventional procedures, and the dual lumen design allows for the delivery of a second guidewire into distal vasculature while leaving the initial guidewire in place. A stiffening mandrel provides support and pushability during catheter insertion.

I am sorry, but the provided text is a 510(k) premarket notification for several medical devices (catheters) and a subsequent administrative correction letter from the FDA. It does not contain information about explicit acceptance criteria or a study that proves a device meets such criteria.

The document establishes that new versions of the Pronto V3 and LP extraction catheters, Skyway RX and OTW support catheters, and Twin-Pass dual access catheter are substantially equivalent to their predicate devices, primarily due to a hydrophilic coating modification.

The "Summary of Studies" section explicitly states:

"Pronto, Skyway and Twin-Pass catheters are substantially equivalent in intended use / indications and design to their predicate devices. Hydrophilic coating design differences have been qualified through biomaterial assessments and verification testing, the results of which did not raise any new safety or performance questions."

This indicates that the submission relies on bench testing (biomaterial assessments and verification testing) to demonstrate that the modified devices perform similarly to their previously cleared predicate devices, rather than a clinical study with defined acceptance criteria for a specific performance metric.

Therefore, I cannot provide the requested information, such as a table of acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, or details about comparative effectiveness studies, as these are not present in the provided text.

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