QHW — Single Lumen Ecmo Cannula Class II
FDA product code QHW covers "Single Lumen Ecmo Cannula", a Class II medical device regulated under 21 CFR 870.4100. Submissions are reviewed by the Cardiovascular panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QHW
- Device Class
- Class II
- Regulation Number
- 870.4100
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
Single-lumen cannulas/catheters to be used with an extracorporeal circuit intended for use in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.