# K141112: Sterling Over-the Wire Pta Balloon Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific
- Decided: Jul 16, 2014 after 77 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: 5 generations back to K001134 (2000). 5 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132430: Sterling Over-the-Wire (Otw) Pta Balloon Dilatation Catheter, Boston Scientific Corp (2013) Summary page 1.

## Most influential descendants
- K192399: Infinity Angioplasty Balloon Catheter (2020), 3 descendants of its own
- K214038: Oscar Peripheral Multifunctional Catheter system (2022), 2 descendants of its own
- K241711: Oscar Peripheral Multifunctional Catheter system (2024), 1 descendant of its own
- K250706: Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (2025), 0 descendants of its own

## Indications for use
The Sterling OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vascutature, 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/K141112
Methodology: https://510kreport.com/methodology