K252527
- 510(k) number
- K252527
- Device name
- Surfacer Inside-Out Access Catheter System
- Applicant
- Merit Medical System, Inc. UT · US
- Product code
- QJH — Reverse Central Venous Recanalization System
- Decision date
- 2025-09-10
- Date received
- 2025-08-11
- Decision
- Unknown
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252527.pdf
Official FDA record: K252527
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.