Spur Peripheral Retrievable Stent System
FDA 510(k) clearance DEN240048 · decided 2025-05-29
Clearance details
- K-number
- DEN240048
- Device name
- Spur Peripheral Retrievable Stent System
- Applicant
- Reflow Medical, Inc.
- Decision
- Unknown
- Date received
- 2024-09-20
- Decision date
- 2025-05-29
- Days to decision
- 251 days
- Clearance type
- Direct
- Product code
- SEU
- Device class
- 2
- Regulation number
- 870.5110
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Clemente, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.