510(k) K191407
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 2020
- Date Received
- May 28, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
- Device Class
- Class II
- Regulation Number
- 870.4100
- Review Panel
- CV
- Submission Type
Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.