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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 the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences. It received FDA 510(k) clearance on 2025-10-21 under 510(k) 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. The listed applicant is Edwards Lifesciences. The 510(k) number is K253034.

When did HemoSphere Stream Module receive FDA 510(k) clearance?

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

Who is the listed applicant for HemoSphere Stream Module?

The FDA 510(k) record lists Edwards Lifesciences as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HemoSphere Stream Module?

The FDA product code for HemoSphere Stream Module is DQK.

Related Clinical Trials

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.

NCT02744677COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve DysfunctionRECRUITINGNCT03230747SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral RegurgitationACTIVE_NOT_RECRUITINGNCT03706833Edwards PASCAL CLASP IID/IIF Pivotal Clinical TrialACTIVE_NOT_RECRUITINGNCT03745313Edwards CLASP TR EFSCOMPLETEDNCT04097145Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical TrialRECRUITINGNCT04375332Beating Heart Mitral Valve Repair With the HARPOON™ SystemACTIVE_NOT_RECRUITING

Other records listing Edwards Lifesciences 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

View all 81 devices →

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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