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FDA 510(k)

HemoSphere Nano Monitor (HSNANO1)

K-Number: K253186 · 2026-02-24

ApplicantEdwards Lifesciences, LLC
Decision Date2026-02-24
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HemoSphere Nano Monitor (HSNANO1) is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2026-02-24 under approval number K253186. 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 Nano Monitor (HSNANO1)?

HemoSphere Nano Monitor (HSNANO1) is a medical device that received FDA 510(k) clearance on 2026-02-24. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K253186.

When was HemoSphere Nano Monitor (HSNANO1) approved by the FDA?

HemoSphere Nano Monitor (HSNANO1) received FDA 510(k) clearance on 2026-02-24, under approval number K253186.

What company makes HemoSphere Nano Monitor (HSNANO1)?

HemoSphere Nano Monitor (HSNANO1) is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for HemoSphere Nano Monitor (HSNANO1)?

The FDA product code for HemoSphere Nano Monitor (HSNANO1) is DQK.

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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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