MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER— 510(k) K012274

Substantially Equivalent

Medtronic Physio-Control Corp.

FDA 510(k) clearance K012274 for MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER, Substantially Equivalent on 2002-02-05. Applicant: Medtronic Physio-Control Corp..

Clearance details

Applicant: Medtronic Physio-Control Corp.
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 2001-07-19
Decision date: 2002-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

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Adverse events under product code LDD

product code LDD

Death: 38
Malfunction: 522
Total: 560

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.