CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA— 510(k) K032737

Substantially Equivalent

Cordis Europa, N.V.

FDA 510(k) clearance K032737 for CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA, Substantially Equivalent on 2003-10-02. Applicant: Cordis Europa, N.V..

Clearance details

Applicant: Cordis Europa, N.V.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2003-09-04
Decision date: 2003-10-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Warren, NJ, US

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Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.