COOK PACEMAKER CORP. 332T BIPOLAR CARDIAC PULSE GE— 510(k) K851699

Substantially Equivalent

Cook Pacemaker Corp.

FDA 510(k) clearance K851699 for COOK PACEMAKER CORP. 332T BIPOLAR CARDIAC PULSE GE, Substantially Equivalent on 1985-05-16. Applicant: Cook Pacemaker Corp..

Clearance details

Applicant: Cook Pacemaker Corp.
Product code: Code DXY
Advisory panel: Cardiovascular
Date received: 1985-04-24
Decision date: 1985-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leechburg, PA, US

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Adverse events under product code DXY

product code DXY

Death: 240
Injury: 2,328
Malfunction: 2,096
Total: 4,664

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.