# K132789: Flip Introducer Access Kit

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Apr 17, 2014 after 223 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 1.

## Indications for use
The Flip Introducer access kit is used to facilitate placing a guide catheter through the skin into a vein or artery, including but not limited to the radial artery.

Source page: https://510kreport.com/device/K132789
Methodology: https://510kreport.com/methodology