K252707
- 510(k) number
- K252707
- Device name
- Zenith Aspiration Catheter; Disposable Aspiration Tubing Set
- Applicant
- Suzhou Zenith Vascular SciTech Limited CN
- Product code
- NRY — Catheter, Thrombus Retriever
- Decision date
- 2026-05-20
- Date received
- 2025-08-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K252707.pdf
Official FDA record: K252707
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.