GTX 12 GIDEWIRE— 510(k) K100470

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K100470 for GTX 12 GIDEWIRE, Substantially Equivalent on 2010-04-21. Applicant: Medtronic, Inc..

Clearance details

Applicant: Medtronic, Inc.
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2010-02-18
Decision date: 2010-04-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Danvers, MA, 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.