# K011937: Truline Infusion Catheters

- Pathway: 510(k) (Special)
- Applicant: Micro Therapeutics, Inc.
- Decided: Aug 28, 2001 after 68 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) MTI Infusion Catheter: named in the summary without a submission number

## Indications for use
The MTI Reinforced Infusion Catheter is intended to be used for the controlled selective infusion of physician-specified pharmacologic agents or radiopaque contrast media into the general vasculature.

Source page: https://510kreport.com/device/K011937
Methodology: https://510kreport.com/methodology