K242520
- 510(k) number
- K242520
- Device name
- Element Vascular Access System
- Applicant
- Penumbra, Inc. CA · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2024-11-20
- Date received
- 2024-08-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K242520.pdf
Official FDA record: K242520
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.