K251446
- 510(k) number
- K251446
- Device name
- PlasmaFlow X Compression Sleeve Device (XPF0001)
- Applicant
- Manamed, LLC TX · US
- Product code
- JOW — Sleeve, Limb, Compressible
- Decision date
- 2025-09-17
- Date received
- 2025-05-09
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K251446
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.