K240885
- 510(k) number
- K240885
- Device name
- Shadow Catheter
- Applicant
- Simpson Interventions, Inc. CA · US
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2024-12-19
- Date received
- 2024-04-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K240885.pdf
Official FDA record: K240885
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.