ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN— 510(k) K984496

Clearance details

Applicant

Atrium Medical Corp.

Product code

Code KDQ

Device class

Class 2

Regulation

21 CFR 880.6740

Advisory panel

General Hospital

Date received

1998-12-17

Decision date

1999-05-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hudson, NH, US

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• K043582 — OCEAN CHEST DRAIN2005-01-21
• K962856 — PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR1996-08-28
• K961287 — ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM1996-07-26

• K130131 — EDRAIN CHEST DRAINAGE SYSTEM2013-02-28
• K122138 — ATRIUM FLIXENE IFG VASCULAR GRAFT2012-08-17
• K121070 — C-QUR RPM MESH2012-04-26
• K113112 — CLEARWAY RX NB CATHETER2011-11-17
• K102596 — ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT2010-10-05

Death

8

Malfunction

637

Total

645

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2592-2021 — Atrium Pneumostat Chest Drain Valve, Part Number 16100Class II·Ongoing·Atrium Medical Corporation·20210826
• Z-1208-2017 — Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Reference: 4000-100N Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal areaClass II·Terminated·Atrium Medical Corporation·20161223

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K984496.