K253667
- 510(k) number
- K253667
- Device name
- Accoat Guide Wire
- Applicant
- Sp Medical A/S DK
- Product code
- DQX — Wire, Guide, Catheter
- Decision date
- 2026-07-14
- Date received
- 2025-11-21
- 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: K253667.pdf
Official FDA record: K253667
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.