FDA 510(k)

Edwards eSheath Optima introducer set

K-Number: K244046 · 2025-03-27

Decision Date2025-03-27

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Edwards eSheath Optima introducer set is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences. It received FDA 510(k) clearance on 2025-03-27 under 510(k) number K244046. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Edwards eSheath Optima introducer set?

Edwards eSheath Optima introducer set is a medical device that received FDA 510(k) clearance on 2025-03-27. The listed applicant is Edwards Lifesciences. The 510(k) number is K244046.

When did Edwards eSheath Optima introducer set receive FDA 510(k) clearance?

Edwards eSheath Optima introducer set received FDA 510(k) clearance on 2025-03-27, under 510(k) number K244046.

Who is the listed applicant for Edwards eSheath Optima introducer set?

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 Edwards eSheath Optima introducer set?

The FDA product code for Edwards eSheath Optima introducer set is DYB.

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 DysfunctionRECRUITING NCT03230747SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral RegurgitationACTIVE_NOT_RECRUITING NCT03706833Edwards PASCAL CLASP IID/IIF Pivotal Clinical TrialACTIVE_NOT_RECRUITING NCT03745313Edwards CLASP TR EFSCOMPLETED NCT04097145Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical TrialRECRUITING NCT04375332Beating Heart Mitral Valve Repair With the HARPOON™ SystemACTIVE_NOT_RECRUITING

Other records listing Edwards Lifesciences as applicant

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Related Devices (Code: DYB)

K253526NAMIC Dilator and SheathMedline Industries, LP K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLC K261242SimplGuidePendracare K261950Health Line Tearaway IntroducerHealth Line International Corporation K261492FieldFlex Steerable SheathCenterPoint Systems, LLC K260606Echo Large Bore Introducer SheathEcho Medical, LLC

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.