K231600
- 510(k) number
- K231600
- Device name
- SENDERO Microcatheter
- Applicant
- Okami Medical, Inc. CA · US
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2023-11-17
- Date received
- 2023-06-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K231600.pdf
Official FDA record: K231600
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.