Prelude IDeal 9F Hydrophilic Sheath Introducer— 510(k) K212152

Name: FDA 510(k) clearance K212152
Creator: U.S. Food and Drug Administration
Published: 2022-01-07

Substantially Equivalent

Merit Medical Systems

FDA 510(k) clearance K212152 for Prelude IDeal 9F Hydrophilic Sheath Introducer, Substantially Equivalent on 2022-01-07. Applicant: Merit Medical Systems. Device class: 2.

Clearance details

Applicant: Merit Medical Systems
Product code: Code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 2021-07-09
Decision date: 2022-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Jordan, UT, 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.