# K070159: Prelude Sheath Introducer

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Jun 21, 2007 after 155 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- 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: 3 generations back to K945616 (1995). 4 ancestors in all.
22 later devices descend from it; 5 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050962: Merit Prelude Sheath Introducer, Merit Medical Systems, Inc. (2005) Summary page 1.

## Most influential descendants
- K091006: Itg Vascular Access System, Model 300 (2010), 12 descendants of its own
- K100615: Arstasis Access System (2010), 11 descendants of its own
- K102728: Arstasis Access System (2010), 10 descendants of its own
- K103143: Arstasis One Latchwire Access System (2011), 9 descendants of its own
- K113110: Axera Access System (2011), 8 descendants of its own

## Recalls of this device
- Aug 12, 2024 · Class II · Z-3190-2024: 7F sheath introducers labeled as 7.5F
- Mar 21, 2023 · Class II · Z-1578-2023: Custom sheath Introducer contains incorrect needle size
- Jun 4, 2015 · Class II · Z-1826-2015: Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. This affects one lot, H767887, of catalog number PR0-6F-11-038.

## Indications for use
The Merit PreludeTM Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K070159
Methodology: https://510kreport.com/methodology