K232562
- 510(k) number
- K232562
- Device name
- PowerWire Radiofrequency Guidewire Kit
- Applicant
- Baylis Medical Technologies, Inc. CA
- Product code
- PDU — Catheter For Crossing Total Occlusions
- Decision date
- 2024-02-28
- Date received
- 2023-08-24
- Decision
- Unknown
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K232562.pdf
Official FDA record: K232562
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.