# K152381: Prelude SNAP Splittable Hydrophilic Sheath Introducer

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Oct 30, 2015 after 67 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: 2 generations back to K934901 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143255: Prelude SNAP Splittable Sheath Introducer, Merit Medical Systems, Inc. (2015) Summary page 4.

## Recalls of this device
- Jun 11, 2024 · Class II · Z-2575-2024: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to pat
- Dec 14, 2017 · Class II · Z-0688-2018: Merit Medical Systems, Inc. is voluntarily conducting a recall of specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub.

## Indications for use
For the introduction of various types of pacing leads and catheters to the heart and coronary venous system

Source page: https://510kreport.com/device/K152381
Methodology: https://510kreport.com/methodology