# K113638: Nmi 2.8 Microcatheter

- Pathway: 510(k) (Special)
- Applicant: Navilyst Medical, Inc.
- Decided: Jan 5, 2012 after 27 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000177 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112124: Microcatheter, Navilyst Medical, Inc. (2011) Summary page 1.

## Indications for use
The NIv Microcatheter is intended for use in small vessels and superselective anatomy during diagnostic and interventional procedures in the peripheral vasculature. Upon access of the desired region, the microcatheter can be used for the controlled and selective infusion of diagnostic, therapeutic and embolic materials. All products must be used in accordance with the original manufacturer's instructions for use. The catheter is not intended for use in coronary or neuro- vasculature.

Source page: https://510kreport.com/device/K113638
Methodology: https://510kreport.com/methodology