# K191731: Instylla Microcatheter

- Pathway: 510(k) (Traditional)
- Applicant: Instylla, Inc.
- Decided: Aug 13, 2019 after 46 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: 3 generations back to K052841 (2005). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093052: Crosscath Support Cathter, Cook, Inc. (2009) Summary page 4.

## Most influential descendants
- K200744: Instylla Microcatheter (2020), 2 descendants of its own
- K210808: Instylla Microcatheter 1.2 (2021), 1 descendant of its own
- K261610: Verge™ Microcatheter (2026), 0 descendants of its own

## Indications for use
The Instylla Microcatheter is intended for use in small vessel or super selective anatomy for peripheral diagnostic and interventional procedures. The Instylla Microcatheter can be used for the infusion of diagnostic, embolic, or therapeutic materials into vessels.

Source page: https://510kreport.com/device/K191731
Methodology: https://510kreport.com/methodology