K261310
- 510(k) number
- K261310
- Device name
- FlexTract Deflectable-Rotational Dilator Sheath Set
- Applicant
- Merit Medical Systems, Inc. UT · US
- Product code
- DRE — Dilator, Vessel, For Percutaneous Catheterization
- Decision date
- 2026-07-27
- Date received
- 2026-04-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K261310.pdf
Official FDA record: K261310
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.