ELECTRODE CATHETER, ORTHOGONAL TYPE— 510(k) K841802

Substantially Equivalent

Webster Laboratories, Inc.

FDA 510(k) clearance K841802 for ELECTRODE CATHETER, ORTHOGONAL TYPE, Substantially Equivalent on 1984-10-18. Applicant: Webster Laboratories, Inc..

Clearance details

Applicant: Webster Laboratories, Inc.
Product code: Code LDF
Advisory panel: Cardiovascular
Date received: 1984-05-01
Decision date: 1984-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Altadena, CA, US

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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.