meddevicedb.com FDA Device Reference

Acumen Assisted Fluid Management (AFM) Software Feature

DEN190029 Class II Direct
Decision Date
2020-11-13
Sponsor / Applicant
Edwards Lifesciences

Technical Specification

510(k) Submission ID DEN190029
Product Code QMS
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.5600
Decision Date 2020-11-13
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Acumen Assisted Fluid Management (AFM) Software Feature received FDA 510(k) clearance under submission number DEN190029, sponsored by Edwards Lifesciences. The device was reviewed via the Direct premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2020-11-13.

Classification & Regulation

This clearance is catalogued under FDA product code QMS and 21 CFR 870.5600, within the Cardiovascular review panel as a Class II device.