HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE PILOT 150 GUIDE WIRE WITH HYDROCOAT HYDROPHG— 510(k) K030549

Substantially Equivalent

Guidcorp

FDA 510(k) clearance K030549 for HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE PILOT 150 GUIDE WIRE WITH HYDROCOAT HYDROPHG, Substantially Equivalent on 2003-05-14. Applicant: Guidcorp.

Clearance details

Applicant: Guidcorp
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2003-02-21
Decision date: 2003-05-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Temecula, CA, US

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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.