# K261610: Verge™ Microcatheter

- Pathway: 510(k) (Special)
- Applicant: Instylla, Inc.
- Decided: Jun 11, 2026 after 28 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: 6 generations back to K052841 (2005). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210808: Instylla Microcatheter 1.2, Instylla, Inc. (2021) Summary page 5.
- K200744: Instylla Microcatheter, Instylla, Inc. (2020) Summary page 5.

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

Source page: https://510kreport.com/device/K261610
Methodology: https://510kreport.com/methodology