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FDA 510(k)

FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors

K-Number: K242909 · 2025-03-21

ApplicantEdwards Lifesciences, LLC
Decision Date2025-03-21
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2025-03-21 under approval number K242909. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors?

FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors is a medical device that received FDA 510(k) clearance on 2025-03-21. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K242909.

When was FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors approved by the FDA?

FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors received FDA 510(k) clearance on 2025-03-21, under approval number K242909.

What company makes FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors?

FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors?

The FDA product code for FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors is DRS.

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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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