# K132498: Valved Tearaway Introducer Generation II

- Pathway: 510(k) (Special)
- Applicant: Medcomp (Medical Components, Inc.)
- Decided: Nov 25, 2013 after 108 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K170405: BD Curve Ascites Shunt (2017), 0 descendants of its own

## Indications for use
The Valved Tearaway Introducers are intended to obtain central venous access to facilitate catheter insertion into the central venous system.

Source page: https://510kreport.com/device/K132498
Methodology: https://510kreport.com/methodology