SAT CenterFlow Molding Balloon Catheter (IN20-00313)

The CenterFlow Molding Balloon Catheter is a flow-permissive, over-the-wire balloon catheter designed to assist in dilating self-expanding endoprostheses (stent grafts) in large-diameter blood vessels. It features two elongated nylon balloons arranged in a zigzag pattern within a nitinol frame that, when inflated, straighten to expand the device while maintaining a central orifice for blood flow during the procedure.

The device uses two nylon balloons (versus three polyurethane balloons in the predicate), a 9 Fr PEBAX 72D inflation lumen, and a co-axial PEBAX 72D guidewire lumen. It has balloon diameters of 20–46 mm, a 113 cm catheter shaft, and is compatible with 18 Fr introducer sheaths. The zigzag balloon arrangement creates hemodynamic flow permissiveness, whereas the predicate's three-lobe design also maintains flow without complete blockage.

ISO 10555-4 (Intravascular catheters—sterile and single-use catheters, Part 4: Balloon dilatation catheters, 2023-11) and ISO 10555-14 (Part 1: General requirements, 2023-11).

Both devices share the same intended use (dilating self-expanding endoprostheses in large vessels), the same product code (DQY), and comparable essential design features including flow-permissive balloon configurations, over-the-wire operation, radiopaque markers, Y-connector attachment, and 0.035-inch guidewire compatibility. Although the subject device uses two nylon balloons versus the predicate's three polyurethane balloons, both achieve hemodynamic flow maintenance through their respective lobed/zigzag balloon arrangements. Non-clinical testing including benchtop performance, biocompatibility, in vivo safety, and packaging validation demonstrated substantial equivalence.