# K132430: Sterling Over-the-Wire (Otw) Pta Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Oct 17, 2013 after 73 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 K001134 (2000). 4 ancestors in all.
19 later devices descend from it; 5 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053116: Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx, Boston Scientific Corp (2005) Summary page 1.

## Most influential descendants
- K141150: Pta Balloon Dilatation Catheter (2014), 8 descendants of its own
- K141112: Sterling Over-the Wire Pta Balloon Dilatation Catheter (2014), 4 descendants of its own
- K192399: Infinity Angioplasty Balloon Catheter (2020), 3 descendants of its own
- K173894: Jade PTA Balloon Dilatation Catheter (2018), 3 descendants of its own
- K214038: Oscar Peripheral Multifunctional Catheter system (2022), 2 descendants of its own

## Indications for use
The Sterling OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

Source page: https://510kreport.com/device/K132430
Methodology: https://510kreport.com/methodology