MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN.— 510(k) K860466

Substantially Equivalent

Cook Pacemaker Corp.

FDA 510(k) clearance K860466 for MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN., Substantially Equivalent on 1986-02-24. Applicant: Cook Pacemaker Corp..

Clearance details

Applicant: Cook Pacemaker Corp.
Product code: Code DXY
Advisory panel: Cardiovascular
Date received: 1986-02-06
Decision date: 1986-02-24
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.