# K033540: Transxchange Support Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: May 25, 2004 after 197 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: 2 generations back to K935425 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991059: Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018 Support Catheter, Model 518-017, Spectranetics Corp. (1999) Summary page 1.

## Indications for use
The TransXchange Support Catheter is a guidewire exchange and infusion device designed for use in the peripheral vascular system. The catheter is intended to support a guidewire during access of vessels, allow for exchange of guidewires, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Source page: https://510kreport.com/device/K033540
Methodology: https://510kreport.com/methodology