# K060519: Introducer Assembly with Rotator Lock

- Pathway: 510(k) (Special)
- Applicant: Teleflex Medical
- Decided: May 5, 2006 after 67 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: 1 generation back to K993191 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993191: TFX Medical Introducer Assembly, Tfx Medical, Inc. (2000) Summary page 2.

## Most influential descendants
- K123974: Percutaneous Introducer Kit (2013), 0 descendants of its own

## Indications for use
The Introducer Assembly with Rotator Lock is intended to provide access to the venous system for device entry, when used in conjunction with additional percutaneous entry devices.

Source page: https://510kreport.com/device/K060519
Methodology: https://510kreport.com/methodology