# K221832: SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cordis US Corp
- Decided: Aug 22, 2022 after 60 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: 4 generations back to K042537 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102035: Sleek Otw Pta Catheters, ClearStream Technologies, Ltd. (2010) Summary page 4.
- K072947: Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters, ClearStream Technologies, Ltd. (2008) Summary page 4.

## Indications for use
The SABERTM .014 and SABERXTM .014 PTA Dilatation Catheters are intended to dilate stenoses in the peripheral vasculature, including femoral, popliteal and infra popliteal arteries. The device is also indicated for postdilation of balloon-expandable and self-expanding stents in the peripheral vasculature.

Source page: https://510kreport.com/device/K221832
Methodology: https://510kreport.com/methodology