# K082063: Prelude Short Sheath Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Oct 15, 2008 after 86 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 19 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K961780 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961780: Hemodialysis Introducer Set, Thomas Medical Products, Inc. (1996) Summary page 1.

## Most influential descendants
- K122190: Prelude 7F Short Sheath Introducer (2012), 0 descendants of its own

## Recalls of this device
- Jul 21, 2021 · Class II · Z-2243-2021: There is a potential that a package sheath contains an incorrect dilator.
- Feb 16, 2017 · Class I · Z-1497-2017: Merit Medical Systems, Inc. announces a voluntary field action for sheaths included with the 7F Prelude¿ Short Sheath Introducers because the sheath marker tips may detach during use.
- Dec 17, 2010 · Not classified · Z-0941-2011: Introducer tips may detach and embolize during use, or the tip material may elicit a thrombogenic response.
- Sep 29, 2009 · Not classified · Z-0518-2010: Potential sterility breach caused by excessive shipment damage.
- Sep 29, 2009 · Not classified · Z-0517-2010: Potential sterility breach caused by excessive shipment damage.
- Apr 14, 2009 · Not classified · Z-1406-2009: External tubing may separate during use, allowing blood loss.
- Apr 14, 2009 · Not classified · Z-1404-2009: External tubing may separate during use, allowing blood loss.
- Apr 14, 2009 · Not classified · Z-1403-2009: External tubing may separate during use, allowing blood loss.
- Apr 14, 2009 · Not classified · Z-1407-2009: External tubing may separate during use, allowing blood loss.
- Apr 14, 2009 · Not classified · Z-1408-2009: External tubing may separate during use, allowing blood loss.
- Apr 14, 2009 · Not classified · Z-1414-2009: External tubing may separate during use, allowing blood loss.
- Apr 14, 2009 · Not classified · Z-1415-2009: External tubing may separate during use, allowing blood loss.
- Apr 14, 2009 · Not classified · Z-1413-2009: External tubing may separate during use, allowing blood loss.
- Apr 14, 2009 · Not classified · Z-1402-2009: External tubing may separate during use, allowing blood loss.
- Apr 14, 2009 · Not classified · Z-1410-2009: External tubing may separate during use, allowing blood loss.
- Apr 14, 2009 · Not classified · Z-1409-2009: External tubing may separate during use, allowing blood loss.
- Apr 14, 2009 · Not classified · Z-1647-2009: External tubing may separate during use, allowing blood loss.
- Apr 14, 2009 · Not classified · Z-1405-2009: External tubing may separate during use, allowing blood loss.
- Apr 14, 2009 · Not classified · Z-1412-2009: External tubing may separate during use, allowing blood loss.

## Indications for use
Merit's Prelude® Short 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. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access.

Source page: https://510kreport.com/device/K082063
Methodology: https://510kreport.com/methodology