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FDA 510(k)

HemoSphere Stream Module

K-Number: K253034 · 2025-10-21

ApplicantEdwards Lifesciences
Decision Date2025-10-21
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HemoSphere Stream Module is a medical device manufactured by Edwards Lifesciences. It received FDA 510(k) clearance on 2025-10-21 under approval number K253034. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HemoSphere Stream Module?

HemoSphere Stream Module is a medical device that received FDA 510(k) clearance on 2025-10-21. It is manufactured by Edwards Lifesciences. The 510(k) number is K253034.

When was HemoSphere Stream Module approved by the FDA?

HemoSphere Stream Module received FDA 510(k) clearance on 2025-10-21, under approval number K253034.

What company makes HemoSphere Stream Module?

HemoSphere Stream Module is manufactured by Edwards Lifesciences.

What is the FDA product code for HemoSphere Stream Module?

The FDA product code for HemoSphere Stream Module is DQK.

Related Clinical Trials

NCT02343601 Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery COMPLETED NCT05404880 INSPIRIS China PMCF Study ACTIVE_NOT_RECRUITING

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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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