ATRIAL J TEMPORARY PACING ELECTRODESS— 510(k) K821333

Substantially Equivalent

Medics Instrument Corp.

FDA 510(k) clearance K821333 for ATRIAL J TEMPORARY PACING ELECTRODESS, Substantially Equivalent on 1982-06-02. Applicant: Medics Instrument Corp..

Clearance details

Applicant: Medics Instrument Corp.
Product code: Code LDF
Advisory panel: Cardiovascular
Date received: 1982-05-05
Decision date: 1982-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LDF

product code LDF

Death: 19
Injury: 188
Malfunction: 694
Other: 1
Total: 902

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.