# K123974: Percutaneous Introducer Kit

- Pathway: 510(k) (Traditional)
- Applicant: Teleflex, Inc.
- Decided: Feb 21, 2013 after 57 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: 4 generations back to K000824 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060519: Introducer Assembly with Rotator Lock, Teleflex Medical (2006) Summary page 1.
- K102540: Ptfe Portable Introducer, Great Batch Medical (2010) Summary page 1.

## Indications for use
This product is to assist in the introduction of diagnostic or therapeutic devices into a vessel.

Source page: https://510kreport.com/device/K123974
Methodology: https://510kreport.com/methodology