# K134031: Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Jul 21, 2014 after 202 days
- Product code: LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.5100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K890505 (1989). 76 ancestors in all.
No later device cites it as a predicate yet.
3 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130391: Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca Dilatation Catheter, Emerge Over-the-Wire Ptca Dilat, Boston Scientific Corp (2013) Summary page 1.
- K102725: Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000, Stingray Guidewire Model M-3004 and M, Bridge Medical, Inc. (2011) Summary page 1.
- K111295: .014 Monorail and Otw Pta Balloon Dilatation Catheters, Boston Scientific Corporation (2011) Summary page 2.
- K083127: Asahi Corsair Microcatheter, Asahi Intecc Co., Ltd. (2009) Summary page 1.

## Indications for use
The Threader Micro-Dilatation Catheters are indicated for pre-dilatation of the stenotic portion of a coronary artery or bypass graft stenosis ( ! 70% stenosis) for the purpose of improving myocardial perfusion. The Threader Micro-Dilatation Catheters are intended to provide support to facilitate the placement of guidewires in the coronary vasculature. The Threader Over-The-Wire Micro-Dilatation Catheter can also be used to exchange one guidewire for another. The Threader Over-The-Wire Micro-Dilatation Catheter is also intended to allow hand-injection of contrast media into the coronary vasculature.

Source page: https://510kreport.com/device/K134031
Methodology: https://510kreport.com/methodology