510(k) DEN240048
- Device
- Spur Peripheral Retrievable Stent System
- Applicant
- Reflow Medical, Inc.
- 510(k) number
- DEN240048
- Product code
- SEU
- Decision
- Unknown (DENG)
- Decision date
- 2025-05-29
- Date received
- 2024-09-20
- Regulation
- 870.5110
- Classification name
- Peripheral Temporary And Retrievable Stent System
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Lori Grace
- Address
- 208 Avenida Fabricante, Suite 100 San Clemente CA US 92672 92672
FDA Registration Numbers#
- 3009526986
- 3027058844
- 3008789872
- 2030624
Source Documents#
510(k) summary PDF not indicated by FDA