K232647
- 510(k) number
- K232647
- Device name
- Microcatheter
- Applicant
- Surmodics,Inc. MN · US
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2023-09-29
- Date received
- 2023-08-31
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K232647.pdf
Official FDA record: K232647
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.