# K172081: Maestro Microcatheter

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Aug 4, 2017 after 25 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
Longest line of descent: 2 generations back to K973645 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082613: Merit Microcatheter, Merit Medical Systems, Inc. (2008) Summary page 4.

## Most influential descendants
- K230636: Maestro Microcatheter (2023), 0 descendants of its own

## Recalls of this device
- Nov 6, 2023 · Class II · Z-0627-2024: The sterility of microcatheter and infusion system devices cannot be guaranteed.

## Indications for use
The Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels. The catheter should not be used in the cerebral vessels.

Source page: https://510kreport.com/device/K172081
Methodology: https://510kreport.com/methodology