# K091006: Itg Vascular Access System, Model 300

- Pathway: 510(k) (Traditional)
- Applicant: Arstasis, Inc.
- Decided: Feb 25, 2010 after 323 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: 4 generations back to K945616 (1995). 12 ancestors in all.
12 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)
- K041486: Vasostasis Vascular Closure System, Cardiva Medical, Inc. (2004) Summary page 1.
- K061075: Boomerang Wire, Cardiva Medical, Inc. (2006) Summary page 1.
- K060190: Super Sheath XL Introducer Sheath, Togo Medikit Co., Ltd. (2006) Summary page 1.
- K070159: Prelude Sheath Introducer, Merit Medical Systems, Inc. (2007). Our reading of the summary gave K071059, FDA’s number for Depuy Spa Porous Coated Proximal Sleeve (DePuy Orthopaedics, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Merit Medical Prelude Introducer Sheath/ Kit”. Summary page 1.

## Most influential descendants
- K100615: Arstasis Access System (2010), 11 descendants of its own
- 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

## 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 ITG Vascular 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 ITG Vascular Access System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.

Source page: https://510kreport.com/device/K091006
Methodology: https://510kreport.com/methodology