# K021638: Ilt Advancing Mechanism, Model A115AMI

- Pathway: 510(k) (Traditional)
- Applicant: Intra Luminal Therapeutics, Inc.
- Decided: Jul 26, 2002 after 67 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- 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 K001992 (2000). 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)
- K001992: Ilt 0.014 Catheter, Model C114NL2, Intra Luminal Therapeutics, Inc. (2000)
- K010531: Ilt Deflecting Catheter, Model C114ND1, Intra Luminal Therapeutics, Inc. (2001)

## Indications for use
The ILT Advancing Mechanism is indicated for use with a guide wire in order to access discreet regions of the vasculature. Once the region has been accessed, the Advancing Mechanism can incrementally advance the guide wire.

Source page: https://510kreport.com/device/K021638
Methodology: https://510kreport.com/methodology