# K070279: Modification to Hypertransit Infusion Catheter

- Pathway: 510(k) (Special)
- Applicant: Cordis Neurovascular, Inc.
- Decided: Mar 14, 2007 after 44 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K945904 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043538: Hypertransit Infusion Catheter, Cordis Neurovascular, Inc. (2005) Summary page 2.

## Indications for use
The HYPERTRANSITm Infusion Catheter is intended to be used as a mechanism for the infusion of various diagnostic and embolic agents in the coronary, neuro and peripheral vasculatures, for guidewire exchange/support, and for superselective angiography of the peripheral and coronary vessels. The device is also intended to be used for infusion of therapeutic agents in the coronary and peripheral vasculature. All agents must be used in accordance with manufacturer's instructions for use.

Source page: https://510kreport.com/device/K070279
Methodology: https://510kreport.com/methodology