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Aircast Venaflow Elite System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K091700

by Djo, Llc

Identifiers

510(k) Number
K091700 FDA 510(k)
FDA Product Code
JOW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.5800 FDA 510(k)
Regulation Number
870.5800 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Aircast Venaflow Elite System by Djo, Llc — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Djo, Llc

Sources (1)

  • FDA 510(k) K091700 24 fields · synced Jun 18, 2026