K232609
- 510(k) number
- K232609
- Device name
- Micro Ace Advanced Micro Access System
- Applicant
- Merit Medical Systems, Inc. UT · US
- Product code
- DRE — Dilator, Vessel, For Percutaneous Catheterization
- Decision date
- 2023-09-27
- Date received
- 2023-08-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K232609.pdf
Official FDA record: K232609
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.