# K082613: Merit Microcatheter

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Dec 30, 2008 after 113 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K973645 (1997). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973645: Renegade Fiber Braided Microcatheter, Boston Scientific Corp (1997) Summary page 1.

## Most influential descendants
- K161921: SwiftNINJA Microcatheter (2016), 4 descendants of its own
- K190126: Bendit2.7 Steerable Microcatheter (2019), 2 descendants of its own
- K200582: Bendit2.7 Steerable Microcatheter (2020), 1 descendant of its own
- K172081: Maestro Microcatheter (2017), 1 descendant of its own
- K230636: Maestro Microcatheter (2023), 0 descendants of its own

## Recalls of this device
- Sep 26, 2014 · Class II · Z-0162-2015: These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F.
- Dec 6, 2013 · Class II · Z-0614-2014: Merit Medical Systems, Inc. is conducting a recall for 3 lots of Maestro Microcatheters with a graphic discrepancy on the carton/box label end panel. The catheter graphic on the front of the carton bo

## Indications for use
The Merit 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/K082613
Methodology: https://510kreport.com/methodology