K252674
- 510(k) number
- K252674
- Device name
- Solo Pace Fusion System (SOLOFUSE1)
- Applicant
- Solo Pace, Inc. CA · US
- Product code
- DQX — Wire, Guide, Catheter
- Decision date
- 2026-01-09
- Date received
- 2025-08-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K252674.pdf
Official FDA record: K252674
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.