| K-number | K254223 |
| Device name | Next Generation 088 Catheter |
| Applicant | Balt USA, LLC |
| Product code | QJP |
| Device class | Class II |
| Decision date | Apr 16, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.1250 |
The Next Generation 088 Catheter is a single-lumen, flexible catheter with variable stiffness used to introduce interventional devices into peripheral, coronary, and neuro vasculature. It features a hydrophilic coating, marker band for visualization under fluoroscopy, and a luer fitting for accessory attachment and infusion.
The subject device has an inner diameter of 0.088 inches (2.24 mm) and outer diameter of 0.110 inches (2.79 mm), with effective lengths of 110–115 cm. It includes a dilator and additional hemostasis valve accessories not supplied with the predicate. Materials, coating, tip configuration, sterilization method, and packaging are identical to the predicate Next Generation Access Catheter.
ISO 10993-1 (biocompatibility evaluation), ISO 10555-1 (catheter tensile strength and burst pressure), ISO 80369-7 (hub verification), ISO 11135 (ethylene oxide sterilization), ASTM F1980 (accelerated aging), and ISO 13485 (quality management system).
The subject device is substantially equivalent to the predicate Next Generation Access Catheter (K234074) because both share the same intended use, indications, materials, design features, and sterilization method. Minor dimensional differences and additional accessories do not raise new safety or effectiveness questions. Comprehensive bench testing, biocompatibility assessment, and shelf-life studies demonstrate the device meets specifications and performs as intended.
View the full FDA submission: accessdata.fda.gov