K250690
- 510(k) number
- K250690
- Device name
- Penumbra System (Thunderbolt Aspiration Tubing)
- Applicant
- Penumbra, Inc. CA · US
- Product code
- NRY — Catheter, Thrombus Retriever
- Decision date
- 2026-06-10
- Date received
- 2025-03-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K250690.pdf
Official FDA record: K250690
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.