OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE— 510(k) K020896

Name: FDA 510(k) clearance K020896
Creator: U.S. Food and Drug Administration
Published: 2002-06-14

Substantially Equivalent

Osypka Medical, Inc.

FDA 510(k) clearance K020896 for OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE, Substantially Equivalent on 2002-06-14. Applicant: Osypka Medical, Inc.. Device class: 2.

Clearance details

Applicant: Osypka Medical, Inc.
Product code: Code DTE
Device class: Class 2
Regulation: 21 CFR 870.3600
Advisory panel: Cardiovascular
Date received: 2002-03-19
Decision date: 2002-06-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: La Jolla, CA, US

Download summary PDF View on FDA.gov ↗

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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.