DEN240048
- 510(k) number
- DEN240048
- Device name
- Spur Peripheral Retrievable Stent System
- Applicant
- Reflow Medical, Inc. CA · US
- Product code
- SEU — Peripheral Temporary And Retrievable Stent System
- Decision date
- 2025-05-29
- Date received
- 2024-09-20
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Cardiovascular
Official FDA record: DEN240048
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.