# K080982: Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Jul 14, 2008 after 98 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.
35 later devices descend from it; 6 cite it directly.
0 of 40 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
- K093720: Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL Over-the-Wire Balloon Dilatation Catheters Model Vario (2009), 21 descendants of its own
- K093636: Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters Model H74939334XXXXXXX (2009), 10 descendants of its own
- K111295: .014 Monorail and Otw Pta Balloon Dilatation Catheters (2011), 9 descendants of its own
- K141150: Pta Balloon Dilatation Catheter (2014), 8 descendants of its own
- K101062: Glider Pta Balloon Catheter (2010), 8 descendants of its own

## Indications for use
The Sterling ES MR and OTW PTA Balloon Dilatation Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, iliofemoral, popliteal, infrapopliteal 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/K080982
Methodology: https://510kreport.com/methodology