# K150932: Sheath Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Bioteque Corp.
- Decided: Jul 22, 2016 after 473 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K945616 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050962: Merit Prelude Sheath Introducer, Merit Medical Systems, Inc. (2005) Summary page 4.

## Indications for use
The Bioteq Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K150932
Methodology: https://510kreport.com/methodology