AIRCAST VENAFLOW ELITE SYSTEM— 510(k) K091700

Substantially Equivalent

Djo, LLC

FDA 510(k) clearance K091700 for AIRCAST VENAFLOW ELITE SYSTEM, Substantially Equivalent on 2009-07-09. Applicant: Djo, LLC. Device class: 2.

Clearance details

Applicant: Djo, LLC
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2009-06-10
Decision date: 2009-07-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Vista, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K091700

K-number listed on FDA's recall record

Z-1661-2013 — VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis.Class II·Terminated·DJO, LLC·20130528

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091700.

Data sourced from openFDA. This site is unofficial and independent of the FDA.