K231218
- 510(k) number
- K231218
- Device name
- Distal Access Catheter
- Applicant
- Accumedical Beijing , Ltd. CN
- Product code
- QJP — Catheter, Percutaneous, Neurovasculature
- Decision date
- 2024-01-19
- Date received
- 2023-04-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K231218.pdf
Official FDA record: K231218
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.