FDA 510(k)

Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform

K-Number: K203224 · 2021-07-30

Decision Date2021-07-30

Product CodeQAQ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2021-07-30 under 510(k) number K203224. The device is classified under product code QAQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform?

Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K203224.

When did Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform receive FDA 510(k) clearance?

Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform received FDA 510(k) clearance on 2021-07-30, under 510(k) number K203224.

Who is the listed applicant for Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform?

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform?

The FDA product code for Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform is QAQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05083403HPI (Hypotension Prediction Index) Care TrialTERMINATED NCT02744677COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve DysfunctionRECRUITING NCT03230747SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral RegurgitationACTIVE_NOT_RECRUITING NCT03706833Edwards PASCAL CLASP IID/IIF Pivotal Clinical TrialACTIVE_NOT_RECRUITING NCT03745313Edwards CLASP TR EFSCOMPLETED NCT04097145Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical TrialRECRUITING

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Related Devices (Code: QAQ)

K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC K183646Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - PressureEdwards Lifeciences, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.