7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH— 510(k) K802481

Substantially Equivalent

Waters Assoc., Inc.

FDA 510(k) clearance K802481 for 7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH, Substantially Equivalent on 1980-10-31. Applicant: Waters Assoc., Inc..

Clearance details

Applicant: Waters Assoc., Inc.
Product code: Code DYG
Advisory panel: Cardiovascular
Date received: 1980-10-07
Decision date: 1980-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DYG

product code DYG

Death: 18
Malfunction: 1,051
Other: 1
Total: 1,070

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.