0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm)— 510(k) K143093

Name: FDA 510(k) clearance K143093
Creator: U.S. Food and Drug Administration
Published: 2015-06-24

Substantially Equivalent

Hotspur Technologies, Inc.,

FDA 510(k) clearance K143093 for 0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm), Substantially Equivalent on 2015-06-24. Applicant: Hotspur Technologies, Inc.,. Device class: 2.

Clearance details

Applicant: Hotspur Technologies, Inc.,
Product code: Code LIT
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2014-10-28
Decision date: 2015-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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K252512 — Armada 14 NC PTA Catheter2026-02-13
K251915 — Amethyst HP PTA OTW 0.035 Catheter2025-12-18
K250706 — Passeo-35 Xeo Peripheral Dilatation Catheter +5 more2025-04-04

More clearances from Hotspur Technologies, Inc.,

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K142300 — Arrow GPSCath Balloon Dialation Catheter (150 cm)2014-09-17

Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.