K252794
- 510(k) number
- K252794
- Device name
- Vision-MR Diagnostic Catheter
- Applicant
- Imricor Medical Systems, Inc. MN · US
- Product code
- DRF — Catheter, Electrode Recording, Or Probe, Electrode R
- Decision date
- 2026-01-08
- Date received
- 2025-09-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K252794.pdf
Official FDA record: K252794
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.