# K110051: Radialsource Transradial Access Introducer Kit

- Pathway: 510(k) (Traditional)
- Applicant: Great Batch Medical
- Decided: Feb 2, 2012 after 391 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). 9 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082644: Glidesheath, Terumo Medical Corp. (2008) Summary page 1.
- K962746: Cordis Avanti Trans-Radial Catheter Sheath Introducer Kit, Cordis Corp. (1996) Summary page 1.

## Most influential descendants
- K132592: Flexor Radial Hydrophilic Introducer Access Set (2014), 2 descendants of its own
- K152044: Flexor Radial Hydrophilic Introducer Access Set (2015), 1 descendant of its own
- K171609: Check-Flo Performer Introducer Micropuncture Radial Artery Access Set (2018), 0 descendants of its own

## Recalls of this device
- May 31, 2013 · Class II · Z-1608-2013: Cordis Corporation, Inc and Greatbatch Medical are recalling one lot of the cordis RADIALSOURCE Spring Wire Transradial Access Kit product. Some units were manufactured with an undersized vessel dilat

## Indications for use
The RadialSource Catheter Sheath Introducer is indicated for use in arterial or venous procedures requiring percutaneous introduction of intravascular devices.

Source page: https://510kreport.com/device/K110051
Methodology: https://510kreport.com/methodology