# K161921: SwiftNINJA Microcatheter

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Nov 4, 2016 after 114 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K960806 (1996). 12 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 17 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.
- K072526: Micrus Courier Enzo Microcatheter 0.0190, Micrus Endovascular Corporation (2007) Summary page 4.
- K070456: Micrus Courier Enzo Microcatheter 0.017, Micrus Endovascular Corporation (2007) Summary page 4.

## Most influential descendants
- K190126: Bendit2.7 Steerable Microcatheter (2019), 2 descendants of its own
- K200582: Bendit2.7 Steerable Microcatheter (2020), 1 descendant of its own
- K211110: Agile Devices Angler Steerable, Deflectable Microcatheter (2022), 0 descendants of its own
- K211525: SwiftNINJA Steerable Microcatheter (2021), 0 descendants of its own

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

Source page: https://510kreport.com/device/K161921
Methodology: https://510kreport.com/methodology