K233825
- 510(k) number
- K233825
- Device name
- Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter
- Applicant
- Innovative Health AZ · US
- Product code
- NLH — Catheter, Recording, Electrode, Reprocessed
- Decision date
- 2024-06-07
- Date received
- 2023-12-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K233825.pdf
Official FDA record: K233825
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.