Cleared Traditional

RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARME

K121145 · Renu Medical, Inc. · Cardiovascular
Jun 2012
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K121145 is an FDA 510(k) clearance for the RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARME, a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Renu Medical, Inc. (Everett, US). The FDA issued a Cleared decision on June 12, 2012, 57 days after receiving the submission on April 16, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K121145 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 2012
Decision Date June 12, 2012
Days to Decision 57 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code JOW — Sleeve, Limb, Compressible
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5800

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