Edwards eSheath Introducer Set— 510(k) K162184

Name: FDA 510(k) clearance K162184
Creator: U.S. Food and Drug Administration
Published: 2016-09-02

Substantially Equivalent

Edward Lifesciences

FDA 510(k) clearance K162184 for Edwards eSheath Introducer Set, Substantially Equivalent on 2016-09-02. Applicant: Edward Lifesciences. Device class: 2.

Clearance details

Applicant: Edward Lifesciences
Product code: Code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 2016-08-04
Decision date: 2016-09-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DYB

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K253526 — NAMIC Dilator and Sheath2026-07-29
K261529 — Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C) +2 more2026-07-06
K261242 — SimplGuide2026-06-25
K261950 — Health Line Tearaway Introducer2026-06-22
K261492 — FieldFlex Steerable Sheath2026-06-05

Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.