| K-number | K251376 |
| Device name | LimFlow ARC |
| Applicant | LimFlow, Inc. |
| Product code | PDU |
| Device class | Class II |
| Decision date | May 31, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.1250 |
The LimFlow ARC is a single-use percutaneous catheter device designed to facilitate placement and positioning of guide wires and catheters within the peripheral vasculature. It consists of a cannula, catheter shaft, and deployment handle with control slide, and is used in healthcare facilities such as cardiac catheter labs. The device is not intended for coronary or cerebral vasculature use.
The subject device and predicate device (LimFlow ARC K221541) have identical design specifications, principles of operation, and fundamental technological characteristics. Both devices use similar materials of construction and packaging. The subject device represents only incremental, non-significant modifications to the predicate.
ISO 10993-1 (biocompatibility), ISO 11135:2014/A1:2018 (sterilization), ASTM F1886/F1886M-88/F88M-21 (packaging), ASTM F2096-11(2019) (packaging), ASTM F88/F88M-21 (packaging), ASTM D4169-22 (packaging).
Substantial equivalence is established because there are no changes to intended use, indications for use, principles of operation, or fundamental technological characteristics between the subject and predicate devices. Both devices share similar materials and packaging. Comprehensive biocompatibility testing (cytotoxicity, sensitization, hemocompatibility, pyrogenicity), sterilization validation, and non-clinical performance testing all demonstrated equivalence, with radiopacity and luer fitting tests leveraged from the predicate.
View the full FDA submission: accessdata.fda.gov