# K261808: ISAAC Neurovascular Navigation Catheter

- Pathway: 510(k) (Special)
- Applicant: Microvention Inc. d/b/a Terumo Neuro
- Decided: Jun 30, 2026 after 29 days
- Product code: QJP (Catheter, Percutaneous, Neurovasculature)
- 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: 6 generations back to K010954 (2001). 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)
- K222115: ISAAC Neurovascular Navigation Catheter, MicroVention, Inc. (2023) Summary page 5.

## 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/K261808
Methodology: https://510kreport.com/methodology