# K050962: Merit Prelude Sheath Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: May 6, 2005 after 18 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- 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: 2 generations back to K945616 (1995). 3 ancestors in all.
24 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970392: Cordis Avanti+Catheter Sheath Introducer System, Cordis Corp. (1997) Summary page 2.

## Most influential descendants
- K070159: Prelude Sheath Introducer (2007), 22 descendants of its own
- 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

## Recalls of this device
- Sep 29, 2009 · Not classified · Z-0519-2010: Potential sterility breach caused by excessive shipment damage.

## 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/K050962
Methodology: https://510kreport.com/methodology