# K143093: 0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm)

- Pathway: 510(k) (Traditional)
- Applicant: Hotspur Technologies, Inc.,
- Decided: Jun 24, 2015 after 239 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: 9 generations back to K001134 (2000). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140351: Arrow Gpscath Balloon Dilatation Catheter, Hotspur Technologies,Inc Subsidiary of Teleflex ME (2014) Summary page 4.
- K142300: Arrow GPSCath Balloon Dialation Catheter (150 cm), Hotspur Technologies, Inc., (2014) Summary page 5.

## Indications for use
The 0.018” Arrow® GPSCath™ Balloon Dilatation Catheter (150 cm) is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, 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/K143093
Methodology: https://510kreport.com/methodology