# K211405: Prelude Guide Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Oct 4, 2021 after 151 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K924607 (1993). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181463: DuraSheath Introducer Sheath System, Contract Medical International, GmbH (2018) Summary page 4.

## Most influential descendants
- K223872: Low Profile Companion Sheath (2023), 0 descendants of its own

## Recalls of this device
- May 22, 2024 · Class II · Z-2218-2024: Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may resul
- Mar 14, 2024 · Class II · Z-1874-2024: Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
- Mar 14, 2024 · Class II · Z-1875-2024: Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.

## Indications for use
The Prelude Guide Sheath Introducer is indicated to be used for the introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.

Source page: https://510kreport.com/device/K211405
Methodology: https://510kreport.com/methodology