# K141150: Pta Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Sep 25, 2014 after 143 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: 6 generations back to K001134 (2000). 8 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053118: Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-Xxxxxx, Boston Scientific Corp (2005) Summary page 4.
- K132430: Sterling Over-the-Wire (Otw) Pta Balloon Dilatation Catheter, Boston Scientific Corp (2013) Summary page 4.
- K093720: Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL Over-the-Wire Balloon Dilatation Catheters Model Vario, Boston Scientific Corp (2009) Summary page 4.

## Most influential descendants
- K173894: Jade PTA Balloon Dilatation Catheter (2018), 3 descendants of its own
- K202231: JADE (2020), 1 descendant of its own
- K201794: Jade (2020), 1 descendant of its own
- K181128: Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) (2018), 1 descendant of its own
- K162350: Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018 (2016), 1 descendant of its own

## Indications for use
Sterling™ Monorail™ Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, renal, and carotid 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/K141150
Methodology: https://510kreport.com/methodology