K233445
- 510(k) number
- K233445
- Device name
- Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter
- Applicant
- Integra Lifesciences Production Corporation MA · US
- Product code
- JXG — Shunt, Central Nervous System And Components
- Decision date
- 2024-01-17
- Date received
- 2023-10-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.6 MB · U.S. public domain
Also available from FDA: K233445.pdf
Official FDA record: K233445
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.