510(k) K984496 ยท KDQ Bottle, Collection, Vacuum
ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN
| Applicant | Atrium Medical Corp., Hudson NH, US |
| Decision | Substantially Equivalent, May 5, 1999 |
| Received | Dec 17, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984496
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2021 | Atrium Medical Corporation Atrium Pneumostat Chest Drain Valve, Part Number 16100 Open, Classified |
KDQ | None listed |
| Dec 23, 2016 | Atrium Medical Corporation 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 ex Terminated |
CAC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.