| K-number | K260938 |
| Device name | PATH BGC |
| Applicant | Crossroads Neurovascular, Inc. |
| Product code | QJP |
| Device class | Class II |
| Decision date | Apr 15, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.1250 |
The PATH BGC is a dual-lumen balloon guide catheter indicated for facilitating insertion and guidance of intravascular catheters into blood vessels in the neurovascular system. It features a compliant balloon mounted near the distal end that provides temporary vascular occlusion during angiographic procedures.
The subject device is identical to the predicate (K242392) in all technological characteristics, including materials (Neusoft UR862A Pebax jackets, polyurethane balloon and distal tip, stainless steel braid), dimensions (0.070in inner diameter, 0.0965in outer diameter, 90-105cm lengths), and design features (radiopaque markers, bifurcated luer hub, hydrophilic coating).
ISO 10555-1 (catheter performance testing including burst, leak, and corrosion resistance), ISO 13485 (quality management system), ISO 80369-7 (luer hub compatibility), ASTM F2096-11 (packaging bubble leak), and ASTM F88 Technique A (pouch seal strength).
The subject device is substantially equivalent because it has identical intended use, device operating principle, indications, and technological characteristics as the predicate PATH BGC (K242392). Bench testing confirmed the device meets design specifications and performance requirements; no new questions of safety or effectiveness are raised by the design.
View the full FDA submission: accessdata.fda.gov