# K122190: Prelude 7F Short Sheath Introducer

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Aug 17, 2012 after 24 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K961780 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082063: Prelude Short Sheath Introducer, Merit Medical Systems, Inc. (2008) Summary page 1.

## Indications for use
The Prelude@ 7F 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/K122190
Methodology: https://510kreport.com/methodology