# K160088: Cydar EV

- Pathway: 510(k) (Traditional)
- Applicant: Cydar, Ltd.
- Decided: Jul 7, 2016 after 174 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K913770 (1991). 18 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151598: VesselNavigator Rel. 1.0, Philips Medical Systems Nederland B.V. (2015) Summary page 5.

## Most influential descendants
- K171829: EndoNaut (2017), 3 descendants of its own
- K212383: EndoNaut (2021), 2 descendants of its own
- K222070: EndoNaut (2022), 1 descendant of its own
- K212442: Cydar EV (Series B) and Cydar EV Maps (2021), 1 descendant of its own
- K252500: CARA System (2026), 0 descendants of its own

## Indications for use
Cydar EV provides image guidance by overlaying preoperative 3D vessel anatomy, from a previously acquired contrast-enhanced, diagnostic CT scan, onto live fluoroscopic images in order to assist in the positioning of guidewires, catheters and other endovascular devices. Cydar EV is intended to assist fluoroscopy-guided endovascular procedures in the lower thorax, abdomen and pelvis. Suitable procedures include (but are not limited to) endovascular aortic aneurysm repair (AAA and mid-distal TAA), angioplasty, stenting and embolization in the common iliac, proximal external iliac and proximal internal iliac arteries and corresponding veins. Cydar EV is not intended for use in the X-ray guided procedures in the liver, kidneys or pelvic organs.

Source page: https://510kreport.com/device/K160088
Methodology: https://510kreport.com/methodology