510(k) K221373
K221373 is an FDA 510(k) premarket notification submitted by Livanova Deutschland, GmbH for the device "Essenz HLM". The FDA issued a decision of Substantially Equivalent on March 9, 2023. The device falls under product code DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4220. Livanova Deutschland, GmbH has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 9, 2023
- Date Received
- May 12, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Console, Heart-Lung Machine, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4220
- Review Panel
- CV
- Submission Type