TFX MEDICAL GUIDEWIRE— 510(k) K963320

Substantially Equivalent

Tfx Medical Group

FDA 510(k) clearance K963320 for TFX MEDICAL GUIDEWIRE, Substantially Equivalent on 1996-12-03. Applicant: Tfx Medical Group.

Clearance details

Applicant: Tfx Medical Group
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 1996-08-23
Decision date: 1996-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jeffrey, NH, 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.