510(k) K232291
K232291 is an FDA 510(k) premarket notification submitted by Livanova Deutschland, GmbH for the device "Essenz HLM, Essenz ILBM". The FDA issued a decision of Substantially Equivalent on August 24, 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
- August 24, 2023
- Date Received
- August 1, 2023
- Clearance Type
- Special
- 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