# K090394: Valved Tearway Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp
- Decided: Sep 1, 2009 after 196 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 K932323 (1993). 8 ancestors in all.
12 later devices descend from it; 4 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040150: Modification to Medamicus Flowguard Peelable Introducer, Medamicus, Inc. (2004) Summary page 1.
- K053092: Medcomp Vascu-Sheath II, Medcomp (2006) Summary page 1.

## Most influential descendants
- K122422: Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable Introducer (2012), 4 descendants of its own
- K160437: PleurX Peritoneal Catheter System (2016), 2 descendants of its own
- K120617: Ptfe Super Sheath Introducer (2012), 2 descendants of its own
- K121849: Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion Stylet, Pleurx Integral Valved Pee (2012), 2 descendants of its own
- K201155: PleurX Peritoneal Catheter System (2020), 1 descendant 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/K090394
Methodology: https://510kreport.com/methodology