K242075
- 510(k) number
- K242075
- Device name
- Indigo® Aspiration System Lightning Bolt Aspiration Tubing
- Applicant
- Penumbra, Inc. CA · US
- Product code
- QEW — Peripheral Mechanical Thrombectomy With Aspiration
- Decision date
- 2024-09-25
- Date received
- 2024-07-16
- 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: K242075.pdf
Official FDA record: K242075
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.