Cleared Traditional

KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE

K040649 · Tyco Healthcare · Cardiovascular
Jul 2004
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K040649 is an FDA 510(k) clearance for the KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE, a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Tyco Healthcare (Mansfield, US). The FDA issued a Cleared decision on July 15, 2004, 126 days after receiving the submission on March 11, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K040649 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 2004
Decision Date July 15, 2004
Days to Decision 126 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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