ELECATH FLUID-DRAIN ASSEMBLY— 510(k) K803002

Substantially Equivalent

Electro-Catheter Corp.

FDA 510(k) clearance K803002 for ELECATH FLUID-DRAIN ASSEMBLY, Substantially Equivalent on 1980-12-22. Applicant: Electro-Catheter Corp..

Clearance details

Applicant: Electro-Catheter Corp.
Product code: Code DQR
Advisory panel: Cardiovascular
Date received: 1980-11-25
Decision date: 1980-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQR

product code DQR

Death: 2
Total: 2

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.