CORDIS MARKER WIRE STEERABLE GUIDEWIRE (STABILIZER WITH RADIOPAQUE MARKERS) AND (WIZDOM WITH RADIOPAQUE MARKERS)— 510(k) K962765

Substantially Equivalent

Cordis Corp.

FDA 510(k) clearance K962765 for CORDIS MARKER WIRE STEERABLE GUIDEWIRE (STABILIZER WITH RADIOPAQUE MARKERS) AND (WIZDOM WITH RADIOPAQUE MARKERS), Substantially Equivalent on 1997-02-21. Applicant: Cordis Corp..

Clearance details

Applicant: Cordis Corp.
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 1996-07-16
Decision date: 1997-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Lakes, FL, 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.