# K112124: Microcatheter

- Pathway: 510(k) (Abbreviated)
- Applicant: Navilyst Medical, Inc.
- Decided: Aug 19, 2011 after 25 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: 1 generation back to K000177 (2000). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000177: Renegade HI-Flo Microcatheter, Boston Scientific Corp (2000) Summary page 1.
- K023681: Renegade STC 18 Microcatheter, Boston Scientific Corp (2002). Our reading of the summary gave K023861, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Boston Scientific Renegade STC Microcatheter”.

## Most influential descendants
- K121954: Nmi Microcatheter (2012), 0 descendants of its own
- K113638: Nmi 2.8 Microcatheter (2012), 0 descendants of its own

## Indications for use
The NMI 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/K112124
Methodology: https://510kreport.com/methodology