# K112554: Transradial Artery Access Devices

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: Nov 18, 2011 after 77 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 K954234 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
2 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K780532: Percutaneous Sheath Introducer Kit, Arrow Intl., Inc. (1978) Summary page 1.
- K082644: Glidesheath, Terumo Medical Corp. (2008) Summary page 1.

## Recalls of this device
- Oct 9, 2013 · Class II · Z-0468-2014: There is a risk that the introducer needles packaged within the kits can be partially or fully occluded, which can cause delayed treatment or an adverse event when used on a patient.

## Indications for use
The TransRadial Artery Access Device is intended for use for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.

Source page: https://510kreport.com/device/K112554
Methodology: https://510kreport.com/methodology