ATRIUM DUAL ATS WATER SEAL CHEST DRAIN UNIT— 510(k) K912956
Substantially EquivalentAtrium Medical Corp.
FDA 510(k) clearance K912956 for ATRIUM DUAL ATS WATER SEAL CHEST DRAIN UNIT, Substantially Equivalent on 1991-11-29. Applicant: Atrium Medical Corp..
Clearance details
- Applicant
- Atrium Medical Corp.
- Product code
- Code CAC
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hollis, NH, US
Adverse events under product code CAC
product code CAC- Death
- 11
- Malfunction
- 477
- Total
- 488
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.