# K100615: Arstasis Access System

- Pathway: 510(k) (Special)
- Applicant: Arstasis, Inc.
- Decided: Mar 30, 2010 after 26 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K945616 (1995). 13 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091006: Itg Vascular Access System, Model 300, Arstasis, Inc. (2010) Summary page 1.

## Most influential descendants
- K102728: Arstasis Access System (2010), 10 descendants of its own
- K103143: Arstasis One Latchwire Access System (2011), 9 descendants of its own
- K113110: Axera Access System (2011), 8 descendants of its own
- K121521: Axera Access System (2012), 7 descendants of its own
- K123135: Axera 2 Access System Model AXE200 (2013), 6 descendants of its own

## Recalls of this device
- Oct 19, 2010 · Not classified · Z-0993-2011: Device has the potential to fracture and sheath separation during use.

## Indications for use
The Arstasis™ Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. The Arstasis®™ Access System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using SF or 6F introducer sheaths.

Source page: https://510kreport.com/device/K100615
Methodology: https://510kreport.com/methodology