# K073035: Prelude and Prelude Pro Sheath Introducers

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Nov 20, 2007 after 22 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Prelude® Sheath Introducer: named in the summary without a submission number

## Most influential descendants
- K100799: Fortress Introducer Sheath System Model 358813, 358814, 358815 (2011), 10 descendants of its own
- K142357: DuraSheath Introducer Sheath System (2015), 6 descendants of its own
- K181463: DuraSheath Introducer Sheath System (2018), 5 descendants of its own
- K221914: Catapult Guide Sheath (2022), 2 descendants of its own
- K153197: Fortress Introducer Sheath SYstem (2016), 2 descendants of its own

## Indications for use
The Prelude® 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/K073035
Methodology: https://510kreport.com/methodology