BlueDop Vascular Expert
FDA 510(k) clearance K260700 · decided 2026-07-08
Clearance details
- K-number
- K260700
- Device name
- BlueDop Vascular Expert
- Applicant
- BlueDop Medical, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2026-03-04
- Decision date
- 2026-07-08
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- DPW
- Device class
- 2
- Regulation number
- 870.2100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- London, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.