| K-number | K251044 |
| Device name | 93 NeuFlex Catheter |
| Applicant | Piraeus Medical |
| Product code | QJP |
| Device class | Class II |
| Decision date | May 23, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.1250 |
The 93 NeuFlex Catheter is a single-lumen guide catheter with a hydrophilic coating designed to provide access to peripheral, coronary, and neuro vasculature for introduction of interventional devices. It features a hollow tube with metal coils/braids and medical-grade polymers, a soft distal tip, radiopaque marker, and is compatible with 0.035-inch or smaller guidewires.
The subject device has an inner diameter of 0.093 inches and outer diameter of 0.110 inches, compared to the predicate's 0.087 inches inner and 0.100 inches outer diameter. Both devices share identical effective lengths (100 and 110 cm), straight atraumatic tip design, hydrophilic coating, materials composition, sterilization method (ethylene oxide), and packaging configuration with loading tool.
ISO 10555-1 (percutaneous catheters), ISO 11135 (ethylene oxide sterilization), ASTM F1980 (accelerated aging), and FDA guidance documents for PTA and Specialty Catheters. Tests included dimensional verification, trackability, flexibility, kink resistance, compatibility with guidewires and interventional devices, leakage testing, pushability, torque strength, and coating integrity.
The 93 NeuFlex and predicate 87 NeuGlide share identical intended use, classification, and core technological design (materials, coating, tip design, lengths, sterilization). The dimensional differences (0.093 vs. 0.087 inch inner diameter, 0.110 vs. 0.100 outer diameter) represent minor size variations that do not raise new safety or effectiveness questions. All performance testing showed equivalent or superior results to the predicate, and biocompatibility was adopted from the cleared predicate, supporting substantial equivalence.
View the full FDA submission: accessdata.fda.gov