# K983003: 1 Mass Transit Infusion Catheter, 1 Various

- Pathway: 510(k) (Special)
- Applicant: Cordis Neurovascular, Inc.
- Decided: Sep 17, 1998 after 20 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MASS TRANSIT Infusion Catheters: named in the summary without a submission number

## Most influential descendants
- K043538: Hypertransit Infusion Catheter (2005), 1 descendant of its own
- K070279: Modification to Hypertransit Infusion Catheter (2007), 0 descendants of its own

## Recalls of this device
- Jun 30, 2008 · Not classified · Z-0604-2009: Two lots of Cordis Neurovascular Masstransit Infusion Catheter Kits has the potential for sterile PTFE contamination within the inner lumen of the catheter.

## Indications for use
The MASS TRANSIT Infusion Catheters are indicated for the selective infusion of various diagnostic, therapeutic, and embolic agents into the peripheral, coronary, and neurovasculature.

Source page: https://510kreport.com/device/K983003
Methodology: https://510kreport.com/methodology