K243599
- 510(k) number
- K243599
- Device name
- Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818)
- Applicant
- Arrow International, LLC (A subsidiary of Teleflex, Inc.) NC · US
- Product code
- FOZ — Catheter, Intravascular, Therapeutic, Short-Term Les
- Decision date
- 2025-03-14
- Date received
- 2024-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243599.pdf
Official FDA record: K243599
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.