K260599
- 510(k) number
- K260599
- Device name
- INDIGO® Aspiration System INDIGO Link
- Applicant
- Penumbra, Inc. CA · US
- Product code
- QEW — Peripheral Mechanical Thrombectomy With Aspiration
- Decision date
- 2026-04-24
- Date received
- 2026-02-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K260599.pdf
Official FDA record: K260599
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.