# K102035: Sleek Otw Pta Catheters

- Pathway: 510(k) (Special)
- Applicant: ClearStream Technologies, Ltd.
- Decided: Dec 1, 2010 after 135 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: 3 generations back to K042537 (2004). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093139: Bantam,48XXXXXX, 50XXXXXX, ClearStream Technologies, Ltd. (2009) Summary page 1.

## Most influential descendants
- K221832: SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter (2022), 0 descendants of its own
- K130786: Sleek Otw Pta Catheter (2013), 0 descendants of its own

## Indications for use
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/K102035
Methodology: https://510kreport.com/methodology