The CELLO II balloon guide catheter (Fuji Systems Corporation) has received 510(k) premarket approval from the US Food and Drug Administration (FDA), and can now be marketed in the USA and other FDA-regulated territories for peripheral and neurovascular indications.
Having been deemed “substantially equivalent” to a legally marketed predicate product—Fuji’s FDA-approved CELLO balloon guide catheter—the device was cleared as a Class 2 percutaneous catheter on 9 December 2022.
The CELLO II balloon guide catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neurovasculature systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures.
A description of the device details that it is a coaxial-lumen, braid-reinforced, variable stiffness catheter with one radiopaque ring marker to identify the distal end of the balloon and a bifurcated Luer hub on the proximal end. A compliant urethane balloon is mounted on the distal end too. Each catheter is supplied with inserters, a Y-connector, three-way stopcocks and syringes.
The materials of construction are described as being similar to those used in many other, similar catheters; the shaft is made of polyurethane, polyamide, stainless steel, and fluorine resin, and the balloon is made of urethane. In addition, patient contact is of limited duration at less than 24 hours.
In its 510(k) approval notification, the FDA details that “no clinical testing was deemed necessary to support this premarket notification” owing to the design similarities between CELLO II and the predicate device—as well as the fact that the indications for use, and intended patient population and anatomical sites, are all the same between the two products.
While CELLO is a trademark of and is manufactured by Japan-based company Fuji Systems Corporation, it is distributed in Europe and the USA by Medtronic.