# K133501: Leadliner CS Lead Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Feb 25, 2014 after 103 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- 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.
No later device cites it as a predicate yet.
1 of 7 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 1.

## Indications for use
The LeadLiner CS lead delivery system is intended for the introduction of pacing or dlefibrillator leads.

Source page: https://510kreport.com/device/K133501
Methodology: https://510kreport.com/methodology