# K201377: SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corporation
- Decided: Oct 9, 2020 after 136 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). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152873: Crosstella RX Balloon Dilatation Catheter, KANEKA Corporation (2016) Summary page 4.

## Indications for use
The SABERX RADIANZ™ PTA Catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries. The device is also indicated for post-dilation of balloon-expandable and self-expanding stents in the peripheral vasculature.

Source page: https://510kreport.com/device/K201377
Methodology: https://510kreport.com/methodology