K242757
- 510(k) number
- K242757
- Device name
- Rotarex Atherectomy System
- Applicant
- Bard Peripheral Vascular, Inc. AZ · US
- Product code
- MCW — Catheter, Peripheral, Atherectomy
- Decision date
- 2025-01-30
- Date received
- 2024-09-12
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K242757.pdf
Official FDA record: K242757
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.