K233448
- 510(k) number
- K233448
- Device name
- Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set
- Applicant
- Integra Lifesciences Production Corporation MA · US
- Product code
- JXG — Shunt, Central Nervous System And Components
- Decision date
- 2023-12-19
- Date received
- 2023-10-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K233448.pdf
Official FDA record: K233448
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.