Cleared Special

EXPRESS CHEST DRAIN

K081718 · Atrium Medical Corp. · General Hospital
Jul 2008
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K081718 is an FDA 510(k) clearance for the EXPRESS CHEST DRAIN, a Bottle, Collection, Vacuum (Class II — Special Controls, product code KDQ), submitted by Atrium Medical Corp. (Hudson, US). The FDA issued a Cleared decision on July 25, 2008, 37 days after receiving the submission on June 18, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K081718 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 2008
Decision Date July 25, 2008
Days to Decision 37 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code KDQ — Bottle, Collection, Vacuum
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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