K241399
- 510(k) number
- K241399
- Device name
- Indigo® Lightning Flash Aspiration System Select + Catheter
- Applicant
- Penumbra, Inc. CA · US
- Product code
- QEW — Peripheral Mechanical Thrombectomy With Aspiration
- Decision date
- 2024-06-10
- Date received
- 2024-05-16
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K241399.pdf
Official FDA record: K241399
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.