Prelude Small O.D. Introducer Guide Wire— 510(k) K241521

Name: FDA 510(k) clearance K241521
Creator: U.S. Food and Drug Administration
Published: 2024-12-10

Substantially Equivalent

Merit Medical Systems, Inc.

FDA 510(k) clearance K241521 for Prelude Small O.D. Introducer Guide Wire, Substantially Equivalent on 2024-12-10. Applicant: Merit Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Merit Medical Systems, Inc.
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2024-05-29
Decision date: 2024-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Jordan, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQX

view all

K261281 — CROSSLEAD Standard 035 and CROSSLEAD Stiff 0352026-09-03
K253667 — Accoat Guide Wire2026-07-14
K261640 — Merit MAK Nitinol/Gold-Tungsten Guide Wire2026-07-13
K254137 — InQwire Amplatz Guide Wire2026-05-22
K260544 — FMD Peripheral Guide Wire F-14 Flex 6 +4 more2026-03-20

More clearances from Merit Medical Systems, Inc.

view all

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 DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

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.