ELECATH DUAL MODE TRANSTHORACIC PACING— 510(k) K810312

Substantially Equivalent

Electro-Catheter Corp.

FDA 510(k) clearance K810312 for ELECATH DUAL MODE TRANSTHORACIC PACING, Substantially Equivalent on 1981-03-04. Applicant: Electro-Catheter Corp..

Clearance details

Applicant: Electro-Catheter Corp.
Product code: Code LDF
Advisory panel: Cardiovascular
Date received: 1981-02-05
Decision date: 1981-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.