# K031417: Ilt Safe Cross 0.035 Support Catheter, Model C135SN1

- Pathway: 510(k) (Traditional)
- Applicant: Intra Luminal Therapeutics, Inc.
- Decided: Jul 11, 2003 after 67 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: 3 generations back to K935425 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022138: Spectranetics 0.035 Support Catheter, Model 518-028, Spectranetics Corp. (2002)
- K030984: Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14, Safe Cross Angled Support Catheter, Safe Crot, Intra Luminal Therapeutics, Inc. (2003) Summary page 1.

## Indications for use
The Safe-Cross@.035” Support Catheter is indicated for use with a guide wire in order to access discreet regions of the vasculature. Once the region has been accessed, an exchange of one guide wire for another can occur. The Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Source page: https://510kreport.com/device/K031417
Methodology: https://510kreport.com/methodology