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..
Clearance details
- Applicant
- Atrium Medical Corp.
- Product code
- Code KDQ
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hudson, NH, US
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.