K250031
- 510(k) number
- K250031
- Device name
- Amplatzer Guidewire
- Applicant
- ABBOTT MEDICAL MN · US
- Product code
- DQX — Wire, Guide, Catheter
- Decision date
- 2025-10-03
- Date received
- 2025-01-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250031.pdf
Official FDA record: K250031
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.