Echo Large Bore Introducer Sheath— 510(k) K260606

Name: FDA 510(k) clearance K260606
Creator: U.S. Food and Drug Administration
Published: 2026-04-29

Substantially Equivalent

Echo Medical, LLC

FDA 510(k) clearance K260606 for Echo Large Bore Introducer Sheath, Substantially Equivalent on 2026-04-29. Applicant: Echo Medical, LLC. Device class: 2.

Summary

Echo Medical's Echo Large Bore Introducer Sheath is filed under product code DYB (Introducer, Catheter).

Class II, 21 CFR 870.1340. It came in as a Traditional 510(k), and Cardiovascular is both the classification panel and the review panel.

Echo Medical filed from Irvine, California. Review took 64 calendar days (February 24 to April 29, 2026).

Clearance details

Applicant: Echo Medical, LLC
Product code: Product code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 2026-02-24
Decision date: 2026-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DYB

view all

K262674 — Giranel Guiding Sheath Set2026-10-15
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

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.