K243601
- 510(k) number
- K243601
- Device name
- Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set
- Applicant
- Route 92 Medical, Inc. CA · US
- Product code
- NRY — Catheter, Thrombus Retriever
- Decision date
- 2025-05-19
- Date received
- 2024-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243601.pdf
Official FDA record: K243601
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.