TRI-FLOW CATHETER— 510(k) K875205

Substantially Equivalent

Neurodynamics, Inc.

FDA 510(k) clearance K875205 for TRI-FLOW CATHETER, Substantially Equivalent on 1988-05-31. Applicant: Neurodynamics, Inc..

Clearance details

Applicant: Neurodynamics, Inc.
Product code: Code JXG
Advisory panel: Neurology
Date received: 1987-12-18
Decision date: 1988-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JXG

product code JXG

Death: 76
Injury: 5,632
Malfunction: 2,230
Other: 4
Total: 7,942

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.