Suzhou Zenith Vascular SciTech Limited · Class II · Cleared Jul 30, 2025
| K-number | K243534 |
| Device name | Micro Catheter |
| Applicant | Suzhou Zenith Vascular SciTech Limited |
| Product code | KRA |
| Device class | Class II |
| Decision date | Jul 30, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.1210 |
The Micro Catheter is a sterile, single-use catheter designed for delivery of interventional devices or contrast media into peripheral and neurovasculature. It features a variable stiffness composite construction with a hydrophilic coating, available in three inner diameters (0.017″, 0.021″, 0.027″) and two working lengths (150 cm, 155 cm), with radiopaque markers for fluoroscopic visualization.
The subject device uses polyurethane/PU strain relief and polycarbonate hub, compared to the predicate's Elvax/Dynaflex strain relief and polypropylene hub. Outer dimensions are similar but slightly different (proximal OD 0.81–0.93 mm vs. predicate 0.89–1.09 mm). Both devices share identical inner PTFE layer, stainless steel middle layer, Pebax outer jacket, hydrophilic coating, platinum-iridium markers, straight shapeable tip, ethylene oxide sterilization, and 2-year shelf-life.
ISO 10555-1 (catheter dimensional and performance testing including corrosion, leakage, burst pressure, kink resistance); ISO 80369-20 (hub testing); ISO 10993 series (biocompatibility including cytotoxicity, sensitization, pyrogenicity, hemolysis, thromboresistance); ISO 11135 (sterilization validation); ISO 11607-2 (sterile barrier system validation); ASTM hemolysis test.
The subject and predicate devices share identical indications for use, same product codes (KRA, QJP), and substantially identical materials and construction (PTFE inner, stainless steel reinforcement, Pebax jacket, hydrophilic coating). The material differences in strain relief and hub were addressed through bench testing and biocompatibility studies showing acceptable performance. Bench testing demonstrated comparable flowrate, burst pressure, flexibility, torque strength, and coating lubricity to the predicate. Biocompatibility testing confirmed non-cytotoxic, non-sensitizing, non-pyrogenic, and non-thrombogenic properties. Since the technological differences do not raise new safety or effectiveness questions and performance matches the predicate, substantial equivalence is established.
View the full FDA submission: accessdata.fda.gov