# K162097: InTRAkit

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Nov 17, 2016 after 111 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- 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.
No later device cites it as a predicate yet.
1 of 10 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 4.

## Indications for use
The introducer sheath is used to facilitate placing a catheter through the skin and into a vein or artery, including, but not limited to, the radial artery. The micropuncture needle or IV catheter is used to gain access to a vein or artery, including, but not limited to, the radial artery, for placement of the mini-guidewire. The mini-guidewire is used for placement of the sheath into a vein or artery, including, but not limited to, the radial artery.

Source page: https://510kreport.com/device/K162097
Methodology: https://510kreport.com/methodology