K243432
- 510(k) number
- K243432
- Device name
- Vascular Navigation PAD 2.0; Navigation Software Vascular PAD
- Applicant
- Brainlab AG DE
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2025-07-22
- Date received
- 2024-11-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243432.pdf
Official FDA record: K243432
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.