Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain— 510(k) K201305
Substantially EquivalentAtrium Medical Corporation
FDA 510(k) clearance K201305 for Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain, Substantially Equivalent on 2021-09-03. Applicant: Atrium Medical Corporation.
Clearance details
- Applicant
- Atrium Medical Corporation
- Product code
- Code CAC
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Merrimack, 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.