# K133843: Saber Percutaneous Transluminal Angioplasty Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corporation
- Decided: Jun 27, 2014 after 191 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K001134 (2000). 27 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971010: Peripheral Transluminal Angioplasty Catheters, Cordis Corp. (1997) Summary page 1.
- K121442: Powerflex Pro Percutaneous Transluminal Angioplasty Catheter, Cordis Corporation (2012) Summary page 2.
- K103464: Pacific Xtreme Ptca Balloon Dilatation Catheter, Medtronic, Inc. (2010) Summary page 2.

## Most influential descendants
- K151153: Pirouette 018 (2015), 4 descendants of its own
- K162316: Pirouette 014 (2016), 2 descendants of its own
- K161427: Pirouette 035 (2016), 2 descendants of its own
- K173621: Advocate PTA Catheter (2017), 1 descendant of its own
- K221245: PTA Balloon Dilatation Catheter (2022), 0 descendants of its own

## Recalls of this device
- Jul 19, 2021 · Class II · Z-2235-2021: The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon.

## Indications for use
The SABER PTA Dilatation catheter is intended to dilate stenoses in iliac, femnoral, ii-femoral, popliteal, infra papliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. 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/K133843
Methodology: https://510kreport.com/methodology