K233205
- 510(k) number
- K233205
- Device name
- Distal Access Catheter
- Applicant
- Shanghai Heartcare Medical Technology Co., Ltd. CN
- Product code
- QJP — Catheter, Percutaneous, Neurovasculature
- Decision date
- 2023-12-22
- Date received
- 2023-09-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K233205.pdf
Official FDA record: K233205
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.