# K151877: MicroTract Access System

- Pathway: 510(k) (Special)
- Applicant: Arstasis, Inc.
- Decided: Aug 7, 2015 after 29 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: 14 generations back to K945616 (1995). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103421: Arstasis Dilator Adapter, Arstasis, Inc. (2011) Summary page 4.
- K140287: Axera RX Access System, Arstasis, Inc. (2014) Summary page 4.

## Indications for use
The MicroTract Access System is intended to allow the use of a .018” guidewire with a .035” or .038” guidewire compatible dilator up to 23cm in overall length.

Source page: https://510kreport.com/device/K151877
Methodology: https://510kreport.com/methodology