Prelude IDeal Hydrophilic Sheath Introducer— 510(k) K173750
Substantially EquivalentMerit Medical Systems, Inc.
FDA 510(k) clearance K173750 for Prelude IDeal Hydrophilic Sheath Introducer, Substantially Equivalent on 2018-02-15. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- South Jordan, UT, US
Recent devices under product code DYB
view allMore clearances from Merit Medical Systems, Inc.
view allAdverse 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, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K173750
K-number listed on FDA's recall record- Z-1434-2025 — Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
- Z-1956-2020 — Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173750.
Data sourced from openFDA. This site is unofficial and independent of the FDA.