510(k) K232480
K232480 is an FDA 510(k) premarket notification submitted by Cardiacassist, Inc. for the device "ProtekDuo Veno-Venous Cannula Sets". The FDA issued a decision of Substantially Equivalent on October 6, 2023. The device falls under product code PZS (Dual Lumen Ecmo Cannula), a Class II device regulated under 21 CFR 870.4100. Cardiacassist, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 6, 2023
- Date Received
- August 16, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dual Lumen Ecmo Cannula
- Device Class
- Class II
- Regulation Number
- 870.4100
- Review Panel
- CV
- Submission Type
Long term support greater than 6 hours for acute respiratory or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.