# K173750: Prelude IDeal Hydrophilic Sheath Introducer

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Feb 15, 2018 after 69 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K954234 (1995). 16 ancestors in all.
4 later devices descend from it; 2 cite it directly.
1 of 21 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140543: Preludeease Hydrophilic Sheath Introducer, Merit Medical Systems, Inc. (2014) Summary page 4.
- K150257: PreludeEASE Hydrophilic Sheath Introducer, Merit Medical Systems, Inc. (2015) Summary page 4.

## Most influential descendants
- K212152: Prelude IDeal 9F Hydrophilic Sheath Introducer (2022), 2 descendants of its own
- K232260: Thinline Sheath Introducer (2023), 1 descendant of its own
- K261529: Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04) (2026), 0 descendants of its own
- K250909: Prelude Wave Hydrophilic Sheath Introducer (2025), 0 descendants of its own

## Recalls of this device
- Jan 27, 2025 · Class II · Z-1434-2025: Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
- Sep 12, 2019 · Class II · Z-1956-2020: labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging. The use of

## Indications for use
The Merit Prelude IDeal Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guide wires.

Source page: https://510kreport.com/device/K173750
Methodology: https://510kreport.com/methodology