Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Edwards eSheath+ introducer set

K-Number: K254279 · 2026-04-17

ApplicantEdwards Lifesciences
Decision Date2026-04-17
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Edwards eSheath+ introducer set is a medical device manufactured by Edwards Lifesciences. It received FDA 510(k) clearance on 2026-04-17 under approval number K254279. 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+ introducer set?

Edwards eSheath+ introducer set is a medical device that received FDA 510(k) clearance on 2026-04-17. It is manufactured by Edwards Lifesciences. The 510(k) number is K254279.

When was Edwards eSheath+ introducer set approved by the FDA?

Edwards eSheath+ introducer set received FDA 510(k) clearance on 2026-04-17, under approval number K254279.

What company makes Edwards eSheath+ introducer set?

Edwards eSheath+ introducer set is manufactured by Edwards Lifesciences.

What is the FDA product code for Edwards eSheath+ introducer set?

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

Related Clinical Trials

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

Other Devices by Edwards Lifesciences

K153069Edwards Balloon Catheter DEN190029Acumen Assisted Fluid Management (AFM) Software Feature K200258Edwards eSheath Introducer Set K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) K240596Cerebral Autoregulation Index (CAI) Algorithm K241330Fogarty Fortis Arterial Embolectomy Catheter

View all 16 devices →

Related Devices (Code: DYB)

K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. ModelAccess Scientific, LLC K162097InTRAkitMedtronic Vascular K162769Pinpoint GT Introducer NeedleC.R. Bard, Inc. K153771TXM Guiding SheathTexasmedical Technologies, Inc. K162184Edwards eSheath Introducer SetEdward Lifesciences K153494HQS Introducer (Model 2064-HQS)Alseal

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.

↑