PROGRAMALITH III MODELS 238 & 239— 510(k) K854195

Name: FDA 510(k) clearance K854195
Creator: U.S. Food and Drug Administration
Published: 1986-01-07

Substantially Equivalent

Pacesetter Systems

FDA 510(k) clearance K854195 for PROGRAMALITH III MODELS 238 & 239, Substantially Equivalent on 1986-01-07. Applicant: Pacesetter Systems. Device class: 3.

Clearance details

Applicant: Pacesetter Systems
Product code: Code DXY
Device class: Class 3
Regulation: 21 CFR 870.3610
Advisory panel: Cardiovascular
Date received: 1985-10-15
Decision date: 1986-01-07
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.