ETHICON TEMPORARY CARDIAC PACING WIRE— 510(k) K822155

Substantially Equivalent

ETHICON, Inc.

FDA 510(k) clearance K822155 for ETHICON TEMPORARY CARDIAC PACING WIRE, Substantially Equivalent on 1982-08-24. Applicant: ETHICON, Inc..

Clearance details

Applicant: ETHICON, Inc.
Product code: Code LOF
Advisory panel: Unknown
Date received: 1982-07-23
Decision date: 1982-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code LOF

product code LOF

Death: 3
Injury: 1,058
Total: 1,061

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.