ELECATH PULSATILE PERFUSION PUMP— 510(k) K854975

Substantially Equivalent

Electro-Catheter Corp.

FDA 510(k) clearance K854975 for ELECATH PULSATILE PERFUSION PUMP, Substantially Equivalent on 1986-01-15. Applicant: Electro-Catheter Corp..

Clearance details

Applicant: Electro-Catheter Corp.
Product code: Code KFM
Advisory panel: Cardiovascular
Date received: 1985-12-12
Decision date: 1986-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rahway, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KFM

product code KFM

Death: 109
Injury: 241
Malfunction: 1,779
Total: 2,129

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.