# K130786: Sleek Otw Pta Catheter

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: May 3, 2013 after 43 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 1.

## Indications for use
The Sleek® OTW PTA Catheters are intended for balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.

Source page: https://510kreport.com/device/K130786
Methodology: https://510kreport.com/methodology