K233350
- 510(k) number
- K233350
- Device name
- SINC Support Catheter
- Applicant
- Reflow Medical, Inc. CA · US
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2024-02-08
- Date received
- 2023-09-29
- 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: K233350.pdf
Official FDA record: K233350
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.