K243184
- 510(k) number
- K243184
- Device name
- SAT CenterFlow Molding Balloon Catheter (IN20-00313)
- Applicant
- Strait Access Technologies Holdings ZA
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2025-06-25
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.0 MB · U.S. public domain
Also available from FDA: K243184.pdf
Official FDA record: K243184
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.