TRU-TRAC COILED GUIDEWIRE— 510(k) K880287

Substantially Equivalent

N-S Medical Products

FDA 510(k) clearance K880287 for TRU-TRAC COILED GUIDEWIRE, Substantially Equivalent on 1988-09-12. Applicant: N-S Medical Products.

Clearance details

Applicant: N-S Medical Products
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 1988-01-25
Decision date: 1988-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

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.