K252355
- 510(k) number
- K252355
- Device name
- K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing
- Applicant
- Sb-Kawasumi Laboratories, Inc. JP
- Product code
- PTI — Non-Coring (Huber) Needle
- Decision date
- 2025-11-26
- Date received
- 2025-07-29
- 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: K252355.pdf
Official FDA record: K252355
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.