# K232260: Thinline Sheath Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Inneuroco, Inc.
- Decided: Sep 27, 2023 after 58 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: 9 generations back to K954234 (1995). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 20 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212152: Prelude IDeal 9F Hydrophilic Sheath Introducer, Merit Medical Systems (2022) Summary page 5.

## Most influential descendants
- K261529: Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04) (2026), 0 descendants of its own

## Indications for use
The Thinline 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/K232260
Methodology: https://510kreport.com/methodology