K233207
- 510(k) number
- K233207
- Device name
- Polaris X Unidirectional Steerable Diagnostic Catheter
- Applicant
- Boston Scientific Corporation MN · US
- Product code
- DRF — Catheter, Electrode Recording, Or Probe, Electrode R
- Decision date
- 2023-10-27
- Date received
- 2023-09-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K233207.pdf
Official FDA record: K233207
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.