# K201333: SABER .035 PTA Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corporation
- Decided: Sep 11, 2020 after 115 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). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121442: Powerflex Pro Percutaneous Transluminal Angioplasty Catheter, Cordis Corporation (2012) Summary page 4.

## Most influential descendants
- K210626: SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (2021), 0 descendants of its own

## Indications for use
The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K201333
Methodology: https://510kreport.com/methodology