# K222115: ISAAC Neurovascular Navigation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: MicroVention, Inc.
- Decided: Jan 10, 2023 after 176 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K010954 (2001). 6 ancestors in all.
1 later device descends 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)
- K082385: Chaperon Guiding Catheter, MicroVention, Inc. (2008) Summary page 4.

## Most influential descendants
- K261808: ISAAC Neurovascular Navigation Catheter (2026), 0 descendants of its own

## Indications for use
The ISAAC™ Neurovascular Navigation Catheter is indicated for use in facilitating advancement of catheters through the neuro and peripheral vasculature and introduction of diagnostic agents. The ISAAC™ Neurovascular Navigation Catheter is not intended for use in the coronary vasculature.

Source page: https://510kreport.com/device/K222115
Methodology: https://510kreport.com/methodology