K240529
- 510(k) number
- K240529
- Device name
- 8F Modified Sheath System
- Applicant
- Route 92 Medical, Inc. CA · US
- Product code
- QJP — Catheter, Percutaneous, Neurovasculature
- Decision date
- 2024-10-02
- Date received
- 2024-02-23
- 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: K240529.pdf
Official FDA record: K240529
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.