EXPRESS CHEST DRAIN— 510(k) K081718
Substantially EquivalentAtrium Medical Corp.
FDA 510(k) clearance K081718 for EXPRESS CHEST DRAIN, Substantially Equivalent on 2008-07-25. Applicant: Atrium Medical Corp.. Device class: 2.
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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hudson, NH, US
Recent devices under product code KDQ
view all- K062302 — MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM
- K043582 — OCEAN CHEST DRAIN
- K984496 — ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN
- K962856 — PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR
- K961287 — ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM
More clearances from Atrium Medical Corp.
view allAdverse events under product code KDQ
product code KDQ- Death
- 8
- Malfunction
- 637
- Total
- 645
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K081718
K-number listed on FDA's recall record- Z-1935-2015 — Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
- Z-1936-2015 — Ocean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100
- Z-1937-2015 — Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100
- Z-1938-2015 — EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081718.
Data sourced from openFDA. This site is unofficial and independent of the FDA.