DATASCOPE INTERNAL DEFIBRILLATOR PADDLES— 510(k) K811638

Substantially Equivalent

Datascope Corp.

FDA 510(k) clearance K811638 for DATASCOPE INTERNAL DEFIBRILLATOR PADDLES, Substantially Equivalent on 1981-07-10. Applicant: Datascope Corp..

Clearance details

Applicant: Datascope Corp.
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 1981-06-10
Decision date: 1981-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.