# K152116: 5.5 F Worley Advanced LVI Lateral Vein Introducer

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Aug 27, 2015 after 28 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: 3 generations back to K000659 (2000). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120158: Coronary Sinus Guide and Lateral Vein Introducer Kits, Thomas Medical Products, Inc. (2012) Summary page 4.

## Most influential descendants
- K260459: VANES Delivery System (VDS) (2026), 0 descendants of its own

## Indications for use
The 5.5 F Worley Advanced LVI Lateral Vein Introducer is intended to access the coronary venous system either alone or in a telescopic assembly with other devices. The 5.5 F Worley Advanced LVI Lateral Vein Introducer serve as a conduit to guide devices, including guidewires, pacemaker or defibrillator leads, and catheters, or to deliver contrast medium into specific branches of the coronary venous system. They have direct contact to the inner heart. 5.5 F Worley Advanced LVI Lateral Vein Introducers come with various curve configurations to facilitate sub-selective access to angulated lateral vein branches. 5.5 F Worley Advanced LVI Lateral Vein Introducers are designed as single use devices and for short term application (< 24 hours). Only medical doctors and medical personnel, who are well trained in cardiology, should apply these introducers.

Source page: https://510kreport.com/device/K152116
Methodology: https://510kreport.com/methodology