# K190037: Cronus HP PTA Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corporation
- Decided: Oct 24, 2019 after 289 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: 8 generations back to K001134 (2000). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151141: Cronus HP - High Pressure Peripheral Balloon Catheter, Nipro Medical Corporation (2016) Summary page 4.

## Indications for use
The Cronus HP PTA 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/K190037
Methodology: https://510kreport.com/methodology