# K040481: Safe-Cross Deflecting Catheter, Model C118ND1

- Pathway: 510(k) (Special)
- Applicant: Intra Luminal Therapeutics, Inc.
- Decided: Mar 18, 2004 after 22 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 K010531 (2001). 3 ancestors in all.
26 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)
- K032784: Ilt Safe-Cross Deflecting Catheter, Model C114ND1, Intra Luminal Therapeutics, Inc. (2003) Summary page 1.

## Most influential descendants
- 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
- K131452: Pressurewire; Certus, Certus 300, Aeris, Aeris 300 (2013), 7 descendants of its own

## Indications for use
The ILT Safe-Cross® Deflecting Catheter is indicated to be used in conjunction with a steerable guide wire in order to access discrete regions of the vasculature. Once the region has been accessed, an exchange of one guide wire for another can occur. The 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/K040481
Methodology: https://510kreport.com/methodology