# K053118: Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-Xxxxxx

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Dec 16, 2005 after 39 days
- Product code: DQY (Catheter, Percutaneous)
- 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 K001134 (2000). 3 ancestors in all.
62 later devices descend from it; 9 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050389: Ultra-Soft SV Balloon Dilatation Catheter, Boston Scientific Corp (2005) Summary page 1.

## Most influential descendants
- K063563: Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon Dilatation Catheter (2007), 24 descendants of its own
- K071189: Cordis Aviator Plus Pta Balloon Dilatation Catheter (2007), 23 descendants of its own
- K093720: Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL Over-the-Wire Balloon Dilatation Catheters Model Vario (2009), 21 descendants of its own
- K112797: Powerflex Pro Percutaneous Transluminal Angioplasty Catheter (2012), 10 descendants of its own
- K121442: Powerflex Pro Percutaneous Transluminal Angioplasty Catheter (2012), 9 descendants of its own

## Indications for use
The Sterling TM MonorailTM PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, ilio-femoral, 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/K053118
Methodology: https://510kreport.com/methodology