| K-number | K254046 |
| Device name | BosCATH Support Catheter |
| Applicant | Sonorous NV, Inc. |
| Product code | QJP |
| Device class | Class II |
| Decision date | Apr 21, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.1250 |
The BosCATH™ Support Catheter is a single-lumen catheter with hydrophilic coating and variable stiffness for general intravascular use in the neuro and peripheral vasculature. It facilitates the introduction of diagnostic agents or therapeutic devices and is not intended for coronary arteries.
The BosCATH™ has a dual-layer coil and braid reinforced shaft with thermoplastic polyurethane outer layer, stainless-steel coil/braid and PTFE inner layer, platinum/iridium marker bands, polycarbonate hub, and polyether-based thermoplastic polyurethane strain relief. It is available in multiple lengths (105, 115, 125 cm) with outer diameter of 0.075 inches and accommodates guidewires up to 0.038 inches.
ISO 10555-1, ISO 80369-7, ISO 80369-20, ISO 10993 series (biocompatibility), ASTM F1886, ASTM F2096, ASTM F88, ASTM F756, FDA guidance documents for PTA and specialty catheters.
The BosCATH™ has the same intended use and similar technological characteristics as the predicate SOFIA™ EX Intracranial Support Catheter, with minor material and dimensional variations. Comprehensive bench performance testing and biocompatibility studies demonstrate equivalent safety and effectiveness, with differences that do not raise new safety concerns.
View the full FDA submission: accessdata.fda.gov