# K140351: Arrow Gpscath Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Hotspur Technologies,Inc Subsidiary of Teleflex ME
- Decided: Jul 2, 2014 after 141 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: 7 generations back to K001134 (2000). 9 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111295: .014 Monorail and Otw Pta Balloon Dilatation Catheters, Boston Scientific Corporation (2011) Summary page 1.

## Most influential descendants
- K142300: Arrow GPSCath Balloon Dialation Catheter (150 cm) (2014), 1 descendant of its own
- K191275: All’InCath 035M PTA Balloon Dilatation Catheter (2020), 0 descendants of its own
- K143093: 0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm) (2015), 0 descendants of its own

## Indications for use
The Arrow GPSCathTh Balloon Dilatation Catheter (150 cm) is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, papliteal. infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

Source page: https://510kreport.com/device/K140351
Methodology: https://510kreport.com/methodology