Prelude Wave Hydrophilic Sheath Introducer— 510(k) K250909

Name: FDA 510(k) clearance K250909
Creator: U.S. Food and Drug Administration
Published: 2025-04-25

Substantially Equivalent

Merit Medical Systems, Inc.

FDA 510(k) clearance K250909 for Prelude Wave Hydrophilic Sheath Introducer, Substantially Equivalent on 2025-04-25. Applicant: Merit Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Merit Medical Systems, Inc.
Product code: Code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 2025-03-26
Decision date: 2025-04-25
Decision: Substantially Equivalent
Clearance type: Special
Location: South Jordan, UT, US

Download summary PDF View on FDA.gov ↗

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K261242 — SimplGuide2026-06-25
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K261492 — FieldFlex Steerable Sheath2026-06-05

More clearances from Merit Medical Systems, Inc.

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K261310 — FlexTract Deflectable-Rotational Dilator Sheath Set2026-07-27
K262086 — PreludeSYNC Radial Compression Device2026-07-22
K254073 — StatSeal Disc2026-05-13
K251802 — STAR RF Ablation System2026-02-13
K252892 — SCOUT MD Surgical Guidance System2025-12-19

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.