# K032784: Ilt Safe-Cross Deflecting Catheter, Model C114ND1

- Pathway: 510(k) (Traditional)
- Applicant: Intra Luminal Therapeutics, Inc.
- Decided: Nov 18, 2003 after 71 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 K010531 (2001). 2 ancestors in all.
27 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031692: Safe-Cross Deflecting Catheter, Model C114ND1, Intra Luminal Therapeutics, Inc. (2003)

## Most influential descendants
- K040481: Safe-Cross Deflecting Catheter, Model C118ND1 (2004), 26 descendants of its own
- K062769: Pressurewire Certus, Models 12006 and 12306 (2006), 25 descendants of its own
- K080813: Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), Receiver (2008), 13 descendants of its own
- K132474: Cardiovascular Pressure Measurement (CPM) System, Navvus Catheter (2014), 10 descendants of its own
- K113584: Pressurewire Certus, Certus 300, Aeris, Aeris 300, and Receiver (2012), 8 descendants of its own

## Indications for use
The Safe-Cross@Deflecting Catheter is indicated to be used in conjunction with a steerable guidewire in order to access discrete regions of the vasculature. Once the region has been accessed, an exchange of one guidewire for another can occur. The Safe-Cross@Deflecting 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/K032784
Methodology: https://510kreport.com/methodology