Bard Peripheral Vascular, Inc. · Class II · Cleared Jan 30, 2025
| K-number | K242757 |
| Device name | Rotarex Atherectomy System |
| Applicant | Bard Peripheral Vascular, Inc. |
| Product code | MCW |
| Device class | Class II |
| Decision date | Jan 30, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.4875 |
The Rotarex™ Atherectomy System is a minimally invasive medical device used to remove plaque and blood clots from peripheral arteries, including arteries with stents, stent grafts, or bypass grafts. It consists of a rotating catheter with an abrading head that spins at 40,000-60,000 rpm and is controlled by a separate drive system.
The device has identical intended use, indications, target population, delivery system design, filter design and material, fundamental scientific technology, packaging configuration, and sterilization method compared to the predicate device. The catheter features a rotating helix and head with abrading facets, operates at approximately 40,000-60,000 rpm depending on model size, and comes in 6F and 8F configurations.
Not stated in this summary.
No physical or design changes were made to the Rotarex™ device itself—only clarifications were added to the instructions for use to emphasize procedural steps and anatomical considerations intended to reduce catheter breakage risk. Since the device's technological characteristics, intended use, indications, and safety profile remain identical to the predicate device cleared in 2021, and only labeling has been revised, the device meets the substantial equivalence standard.
View the full FDA submission: accessdata.fda.gov