# K151141: Cronus HP - High Pressure Peripheral Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corporation
- Decided: Jan 14, 2016 after 260 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- 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: 7 generations back to K001134 (2000). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110319: Evercross 0.035 Otw Pta Dilatation Catheter, Ev3, Inc. (2011) Summary page 5.

## Most influential descendants
- K190037: Cronus HP PTA Balloon Catheter (2019), 0 descendants of its own

## Indications for use
The Cronus HP - High Pressure Peripheral Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty in the following vessel areas: - Femoral arteries - Popliteal arteries - Iliac arteries - Renal arteries - For the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. These catheters are not intended for use in coronary arteries or the neurovasculature.

Source page: https://510kreport.com/device/K151141
Methodology: https://510kreport.com/methodology