# K031692: Safe-Cross Deflecting Catheter, Model C114ND1

- Pathway: 510(k) (Traditional)
- Applicant: Intra Luminal Therapeutics, Inc.
- Decided: Aug 22, 2003 after 81 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: 1 generation back to K010531 (2001). 1 ancestor in all.
30 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010531: Ilt Deflecting Catheter, Model C114ND1, Intra Luminal Therapeutics, Inc. (2001)

## Most influential descendants
- K032784: Ilt Safe-Cross Deflecting Catheter, Model C114ND1 (2003), 27 descendants of its own
- 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

## Indications for use
The Safe-Cross@Deflecting Catheter is indicated for use with a guide wire in order to access discreet regions of the vasculature. It may be used to facilitate placement of guide wires and other interventional devices. 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/K031692
Methodology: https://510kreport.com/methodology