3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON— 510(k) K093515

Substantially Equivalent

Brivant, Ltd.

FDA 510(k) clearance K093515 for 3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON, Substantially Equivalent on 2010-02-16. Applicant: Brivant, Ltd..

Clearance details

Applicant: Brivant, Ltd.
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2009-11-13
Decision date: 2010-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Galway, IE

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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.