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

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.,.

Clearance details

Applicant: Hotspur Technologies, Inc.,
Product code: Code LIT
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 ↗

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.