K240030
- 510(k) number
- K240030
- Device name
- Indigo® Aspiration System - Lightning® Flash
- Applicant
- Penumbra, Inc. CA · US
- Product code
- QEW — Peripheral Mechanical Thrombectomy With Aspiration
- Decision date
- 2024-02-02
- Date received
- 2024-01-04
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K240030.pdf
Official FDA record: K240030
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.