# Prelude Guide Sheath

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/prelude-guide-sheath-dyb>
- Manufacturer: [Merit Medical Systems, Inc.](https://devicerts.com/manufacturers/merit-medical-systems-inc) (United States)
- Device class: Class II (US FDA)
- FDA product code: DYB

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K211405 · decision 2021-10-04 · decision SESE · status: Active

## Recalls

- Z-2218-2024 · Class II · ongoing · initiated 2024-05-22: 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 result in the swivel nut detaching from the HVA body.
- Z-1874-2024 · Class II · ongoing · initiated 2024-03-14: Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
- Z-1875-2024 · Class II · ongoing · initiated 2024-03-14: Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.

## Identifiers

- 510(k) Number: K211405 [FDA 510(k)]
- FDA product code: DYB [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 870.1340 [FDA 510(k)]
- Advisory committee: Cardiovascular [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Prelude Guide Sheath, Merit Medical Systems, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/prelude-guide-sheath-dyb (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/prelude-guide-sheath-dyb.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/prelude-guide-sheath-dyb
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.