Cleared Traditional

K093658 - RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL VASOPRESS FOOT GARMENTS
(FDA 510(k) Clearance)

K093658 · Renu Medical, Inc. · Cardiovascular

Jan 2010

Decision

50d

Days

Class 2

Risk

K093658 is an FDA 510(k) clearance for the RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL VASOPRESS FOOT GARMENTS, 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 January 14, 2010, 50 days after receiving the submission on November 25, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number	K093658 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 25, 2009
Decision Date	January 14, 2010
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF