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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 the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2026-02-24 under 510(k) 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. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K253186.

When did HemoSphere Nano Monitor (HSNANO1) receive FDA 510(k) clearance?

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

Who is the listed applicant for HemoSphere Nano Monitor (HSNANO1)?

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 HemoSphere Nano Monitor (HSNANO1)?

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

Related Clinical Trials

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Other records listing Edwards Lifesciences, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P230013Percutaneously Delivered Prostheses and Tricuspid ValvesPMA P860057replacement Heart-valvePMA P250019Prosthesis, mitral valve, percutaneously deliveredPMA P220003Mitral valve repair devicesPMA P200015Pulmonary valve prosthesis percutaneously deliveredPMA P150048heart-valve, non-allograft tissue

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Related Devices (Code: DQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.

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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