K232651
- 510(k) number
- K232651
- Device name
- BLAZER Dx-20 Bidirectional Steerable Diagnostic Catheter
- Applicant
- Boston Scientific Corporation MN · US
- Product code
- DRF — Catheter, Electrode Recording, Or Probe, Electrode R
- Decision date
- 2023-09-29
- Date received
- 2023-08-31
- 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: K232651.pdf
Official FDA record: K232651
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.