DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS— 510(k) K862226

Substantially Equivalent

Pacesetter Systems

FDA 510(k) clearance K862226 for DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS, Substantially Equivalent on 1987-02-03. Applicant: Pacesetter Systems.

Clearance details

Applicant: Pacesetter Systems
Product code: Code DXY
Advisory panel: Cardiovascular
Date received: 1986-06-11
Decision date: 1987-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sylmar, CA, 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.