K240917
- 510(k) number
- K240917
- Device name
- Esperance 3+ Aspiration Catheter System
- Applicant
- Wallaby Medical CA · US
- Product code
- NRY — Catheter, Thrombus Retriever
- Decision date
- 2024-10-01
- Date received
- 2024-04-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K240917.pdf
Official FDA record: K240917
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.