# K181855: RadialSeal Introducer Kit

- Pathway: 510(k) (Traditional)
- Applicant: Great Batch Medical
- Decided: Jul 26, 2018 after 15 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: 6 generations back to K954234 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
1 of 12 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142183: Glidesheath Slender, Terumo Medical Corporation (2014) Summary page 5.

## Indications for use
The RadialSeal™ Introducer Kit is used to facilitate placing a catheter through the skin into the radial artery.

Source page: https://510kreport.com/device/K181855
Methodology: https://510kreport.com/methodology