Cleared Special

OCEAN CHEST DRAIN

K043582 · Atrium Medical Corp. · General Hospital
Jan 2005
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K043582 is an FDA 510(k) clearance for the OCEAN 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 January 21, 2005, 24 days after receiving the submission on December 28, 2004. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K043582 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2004
Decision Date January 21, 2005
Days to Decision 24 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

Similar Devices — KDQ Bottle, Collection, Vacuum

All 47
EXPRESS CHEST DRAIN
K081718 · Atrium Medical Corp. · Jul 2008
MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM
K062302 · Millicore AB · Oct 2006
ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN
K984496 · Atrium Medical Corp. · May 1999
PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR
K962856 · Deknatel, Inc. · Aug 1996
ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM
K961287 · Rocket Medical Plc · Jul 1996
MUCUS SPECIMEN TRAP
K962168 · Sage Products, Inc. · Jul 1996