# K172117: Prelude Pursuit Splittable Sheath Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Sep 11, 2017 after 60 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K791129 (1979). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K791129: Permanent Lead Intraducer, Daig Corp. (1979) Summary page 4.

## Most influential descendants
- K241334: Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter, (2025), 1 descendant of its own
- K251186: Bard® Temporary Pacing Electrode Catheter  Needle / Cannula (Introducer) (2025), 0 descendants of its own

## Recalls of this device
- Jun 11, 2024 · Class II · Z-2572-2024: 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

## Indications for use
The introduction of various types of pacing/defibrillator leads and catheters into the venous vasculature.

Source page: https://510kreport.com/device/K172117
Methodology: https://510kreport.com/methodology