ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR— 510(k) K011461

Substantially Equivalent

Access Cardiosystems, Inc.

FDA 510(k) clearance K011461 for ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR, Substantially Equivalent on 2002-05-28. Applicant: Access Cardiosystems, Inc..

Clearance details

Applicant: Access Cardiosystems, Inc.
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 2001-05-14
Decision date: 2002-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, MA, 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.