# K242276: CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55)

- Pathway: 510(k) (Traditional)
- Applicant: Vantis Vascular, Inc.
- Decided: Sep 30, 2024 after 60 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K935425 (1994). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183353: Telescope Guide Extension Catheter, Medtronic, Inc. (2019) Summary page 5.

## Most influential descendants
- K262817: CrossFAST Integrated Microcatheter Advanced Delivery System (2026), 0 descendants of its own

## Indications for use
The CrossFASTTM Integrated Microcatheter Guide Extension System is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.

Source page: https://510kreport.com/device/K242276
Methodology: https://510kreport.com/methodology