ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATING— 510(k) K984394

Substantially Equivalent

Guidant Corp.

FDA 510(k) clearance K984394 for ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATING, Substantially Equivalent on 1999-03-08. Applicant: Guidant Corp..

Clearance details

Applicant: Guidant Corp.
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 1998-12-08
Decision date: 1999-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, 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.