FDA 510(k)

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

K-Number: K242909 · 2025-03-21

Decision Date2025-03-21

Product CodeDRS

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors 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 2025-03-21 under 510(k) 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. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K242909.

When did FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors receive FDA 510(k) clearance?

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

Who is the listed applicant for FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors?

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 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.

Related Clinical Trials

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Other records listing Edwards Lifesciences, LLC as applicant

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Related Devices (Code: DRS)

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Official Source

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