# K053092: Medcomp Vascu-Sheath II

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp
- Decided: Aug 1, 2006 after 271 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: 2 generations back to K993191 (2000). 2 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 17 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 1.
- K022513: Medcomp Vascu-Sheath Introducer Set, Medcomp (2002) Summary page 1.

## Most influential descendants
- K090394: Valved Tearway Introducer (2009), 12 descendants of its own
- 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

## Indications for use
VASCU-SHEATH® II INTRODUCERS ARE INTENDED TO OBTAIN CENTRAL VENOUS ACCESS TO FACILITATE CATHETER INSERTION INTO THE CENTRAL VENOUS SYSTEM.

Source page: https://510kreport.com/device/K053092
Methodology: https://510kreport.com/methodology