K233433
- 510(k) number
- K233433
- Device name
- Sphere-9Dx Diagnostic Catheter (AFR-00009)
- Applicant
- Medtronic MN · US
- Product code
- MTD — Catheter, Intracardiac Mapping, High-Density Array
- Decision date
- 2024-08-07
- Date received
- 2023-10-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K233433.pdf
Official FDA record: K233433
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.