510(k) DEN160044
DEN160044 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "Acumen Hypotension Prediction Index (HPI) Feature Software". The FDA issued a decision of De Novo Granted on March 16, 2018. The device falls under product code QAQ (Adjunctive Predictive Cardiovascular Indicator), a Class II device regulated under 21 CFR 870.2210. Edwards Lifesciences, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 16, 2018
- Date Received
- September 26, 2016
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adjunctive Predictive Cardiovascular Indicator
- Device Class
- Class II
- Regulation Number
- 870.2210
- Review Panel
- CV
- Submission Type
The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.