# K043538: Hypertransit Infusion Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Neurovascular, Inc.
- Decided: Apr 18, 2005 after 117 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: 4 generations back to K945904 (1995). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983003: 1 Mass Transit Infusion Catheter, 1 Various, Cordis Neurovascular, Inc. (1998) Summary page 2.
- K021591: Prowler Select (10, 14, and Plus) Infusion Catheters with and Without Pre-Shaped Tips, Cordis Neurovascular, Inc. (2002) Summary page 2.
- (no number) Renegade HI-FLO Microcatheter: named in the summary without a submission number

## Most influential descendants
- K070279: Modification to Hypertransit Infusion Catheter (2007), 0 descendants of its own

## Indications for use
The HYPERTRANSITTM 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/K043538
Methodology: https://510kreport.com/methodology