K250552
- 510(k) number
- K250552
- Device name
- Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
- Applicant
- ABBOTT MEDICAL CA · US
- Product code
- DQX — Wire, Guide, Catheter
- Decision date
- 2025-07-25
- Date received
- 2025-02-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K250552.pdf
Official FDA record: K250552
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.