Atraverse Medical · Class II · Cleared Feb 27, 2026
| K-number | K260292 |
| Device name | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) |
| Applicant | Atraverse Medical |
| Product code | DXF |
| Device class | Class II |
| Decision date | Feb 27, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.5175 |
The HOTWIRE RF Guidewire is a sterile, single-use device that delivers radiofrequency energy to create an atrial septal defect in the heart. It consists of a stainless steel core wire with insulating polymer jacket, a floppy distal segment with an uninsulated electrode coil, and tungsten marker for visualization. The device is used with compatible third-party sheaths and RF electrosurgical generators.
The subject device shares identical fundamental design, insulation, dimensions, and tip configuration with the predicate device (K252419). Minor differences include a material change (Dymax 1184-M-T) and core wire grind profile modifications. Both are single-use, gamma-sterilized devices (VDmax25, SAL 10-6) compatible with cleared RF generators.
Non-clinical bench testing per applicable standards including visual inspection, simulated use, arc integrity, fracture resistance, flexing, and tensile strength tests. Biocompatibility assessed with no impact to requirements. Packaging validated per ASTM D4332 (environmental conditioning), ASTM 4169 (transportation simulation), and 1-year accelerated aging.
Substantial equivalence is established through identical indications for use (creation of atrial septal defect), identical fundamental scientific technology (controlled RF energy), identical principles of operation (operator-controlled RF delivery), and identical method of supply (single-use, gamma-sterilized). Minor material and design modifications do not raise new safety or effectiveness questions and all performance testing met specified criteria.
View the full FDA submission: accessdata.fda.gov