K244061
- 510(k) number
- K244061
- Device name
- X-Wire Guidewire
- Applicant
- Imperative Care, Inc. CA · US
- Product code
- MOF — Guide, Wire, Catheter, Neurovasculature
- Decision date
- 2025-08-26
- Date received
- 2024-12-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K244061.pdf
Official FDA record: K244061
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.