GHAJAR INTRAVENTRICULAR CATHETER GUIDE— 510(k) K854475

Substantially Equivalent

Sparta Instrument Corp.

FDA 510(k) clearance K854475 for GHAJAR INTRAVENTRICULAR CATHETER GUIDE, Substantially Equivalent on 1986-02-20. Applicant: Sparta Instrument Corp..

Clearance details

Applicant: Sparta Instrument Corp.
Product code: Code HAW
Advisory panel: Neurology
Date received: 1985-11-07
Decision date: 1986-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

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.