K233900
- 510(k) number
- K233900
- Device name
- Nordica PV Cryo Mapping Catheter
- Applicant
- Synaptic Medical Corporation CA · US
- Product code
- DRF — Catheter, Electrode Recording, Or Probe, Electrode R
- Decision date
- 2024-09-06
- Date received
- 2023-12-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K233900.pdf
Official FDA record: K233900
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.