# K230283: Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428)

- Pathway: 510(k) (Special)
- Applicant: Abbott Medical
- Decided: Mar 1, 2023 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: 1 generation back to K013029 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013029: Seal-Away CS Introducer Kit, Models 407514, 407515, St Jude Medical (2001) Summary page 4.

## Indications for use
The Peel-Away lntroducers are intended to provide a transvenous conduit for the introduction of cardiac leads and catheters into the venous vascular system.

Source page: https://510kreport.com/device/K230283
Methodology: https://510kreport.com/methodology