# K093636: Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters Model H74939334XXXXXXX

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Dec 23, 2009 after 29 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.
10 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080982: Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters, Boston Scientific Corp (2008) Summary page 1.

## Most influential descendants
- K111295: .014 Monorail and Otw Pta Balloon Dilatation Catheters (2011), 9 descendants of its own
- K140351: Arrow Gpscath Balloon Dilatation Catheter (2014), 3 descendants 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
- K150452: ComboCath OTW PTA Dilatation Catheter (2015), 1 descendant of its own
- K142300: Arrow GPSCath Balloon Dialation Catheter (150 cm) (2014), 1 descendant of its own

## Indications for use
The Sterling ES Monorail and Over-the-Wire PTA Balloon Dilatation Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The 2.00 mm - 4.00 mm balloon devices are also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

Source page: https://510kreport.com/device/K093636
Methodology: https://510kreport.com/methodology