PlasmaFlow X Compression Sleeve Device (XPF0001)— 510(k) K251446

Substantially Equivalent

Manamed, LLC

FDA 510(k) clearance K251446 for PlasmaFlow X Compression Sleeve Device (XPF0001), Substantially Equivalent on 2025-09-17. Applicant: Manamed, LLC.

Clearance details

Applicant: Manamed, LLC
Product code: Code JOW
Advisory panel: Cardiovascular
Date received: 2025-05-09
Decision date: 2025-09-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Denton, TX, US

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