K240826
- 510(k) number
- K240826
- Device name
- Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter
- Applicant
- Sterilmed, Inc. MN · US
- Product code
- NLH — Catheter, Recording, Electrode, Reprocessed
- Decision date
- 2024-10-11
- Date received
- 2024-03-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K240826.pdf
Official FDA record: K240826
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.