K242104
- 510(k) number
- K242104
- Device name
- Penumbra System (Reperfusion Catheter RED 72)
- Applicant
- Penumbra, Inc. CA · US
- Product code
- NRY — Catheter, Thrombus Retriever
- Decision date
- 2025-02-13
- Date received
- 2024-07-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K242104.pdf
Official FDA record: K242104
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.