# K170338: A-View

- Pathway: 510(k) (Traditional)
- Applicant: Stroke2prevent B.V.
- Decided: May 16, 2017 after 103 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K935595 (1995). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070515: A-View Basic and Plus, Cordatec N.V. (2007) Summary page 4.

## Indications for use
A-View® is intended for use in conjunction with TEE investigation of the upper mediastinum in anesthetized patients. They allow visibility of the distal ascending aorta by TEE and permit the condition of the ascending aorta to be evaluated before surgery. A-View® is limited for use in adult patients.

Source page: https://510kreport.com/device/K170338
Methodology: https://510kreport.com/methodology