K242319
- 510(k) number
- K242319
- Device name
- Indigo® Aspiration System Aspiration Catheter 6X
- Applicant
- Penumbra, Inc. CA · US
- Product code
- QEW — Peripheral Mechanical Thrombectomy With Aspiration
- Decision date
- 2024-09-03
- Date received
- 2024-08-05
- 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: K242319.pdf
Official FDA record: K242319
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.