K233397
- 510(k) number
- K233397
- Device name
- Cosine-10TM Diagnostic Catheter
- Applicant
- Medtronic, Inc. MN · US
- Product code
- DRF — Catheter, Electrode Recording, Or Probe, Electrode R
- Decision date
- 2023-12-02
- Date received
- 2023-10-03
- 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: K233397.pdf
Official FDA record: K233397
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.