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FDA 510(k)

Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform

K-Number: K203224 · 2021-07-30

ApplicantEdwards Lifesciences, LLC
Decision Date2021-07-30
Product CodeQAQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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

When was Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform approved by the FDA?

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

What company makes Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform?

Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform is manufactured by Edwards Lifesciences, LLC.

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.

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Related PubMed Literature

PMID: 41105489 Medical device shelf-life and recalls: navigating healthcare challenges. Expert review of medical devices (2025) PMID: 41583580 Postmarket Surveillance of Neuroendovascular Devices. Stroke (Hoboken, N.J.) (2024)

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Related Devices (Code: QAQ)

DEN160044Acumen Hypotension Prediction Index (HPI) Feature SoftwareEdwards 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 K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, 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.

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