# K103421: Arstasis Dilator Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Arstasis, Inc.
- Decided: May 24, 2011 after 183 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: 4 generations back to K945616 (1995). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070159: Prelude Sheath Introducer, Merit Medical Systems, Inc. (2007) Summary page 1.

## Most influential descendants
- K151877: MicroTract Access System (2015), 0 descendants of its own

## Indications for use
The Adapter is intended to allow the use of a .018” guidewire with a 035" or .038” guidewire compatible dilator up to 23cm in overall length. “The Adapter is intended to allow the use of a .018” guidewire with a 0.035” or .038” guidewire compatible dilator up to 23 cm in overall length and 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/K103421
Methodology: https://510kreport.com/methodology