MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER— 510(k) K913805

Substantially Equivalent

Pace Medical

FDA 510(k) clearance K913805 for MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER, Substantially Equivalent on 1991-11-19. Applicant: Pace Medical.

Clearance details

Applicant: Pace Medical
Product code: Code DTE
Advisory panel: Cardiovascular
Date received: 1991-08-26
Decision date: 1991-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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Adverse events under product code DTE

product code DTE

Death: 18
Injury: 247
Malfunction: 4,603
Total: 4,868

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.