# K111295: .014 Monorail and Otw Pta Balloon Dilatation Catheters

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: May 31, 2011 after 21 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 3 (0 Class I)
- 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.
9 later devices descend from it; 4 cite it directly.
0 of 18 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.
- K093636: Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters Model H74939334XXXXXXX, Boston Scientific Corp (2009) Summary page 1.
- K093720: Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL Over-the-Wire Balloon Dilatation Catheters Model Vario, Boston Scientific Corp (2009) Summary page 1.

## Most influential descendants
- 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
- K241683: Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031406020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031408020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031410020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031412020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031415020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H749390314 (2024), 0 descendants of its own

## Recalls of this device
- Dec 3, 2025 · Class II · Z-1042-2026: Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for i
- Feb 4, 2014 · Class II · Z-0971-2014: Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote" MONORAIL" PTA Balloon Dilatation Catheter. Boston
- Feb 4, 2014 · Class II · Z-0969-2014: Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote" MONORAIL" PTA Balloon Dilatation Catheter. Boston

## Indications for use
.014 PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, infrapopliteal, popliteal, renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K111295
Methodology: https://510kreport.com/methodology