HAEMOTRONIC BLOOD LINE SET— 510(k) K896407

Substantially Equivalent

Healthcare Suppliers, Inc.

FDA 510(k) clearance K896407 for HAEMOTRONIC BLOOD LINE SET, Substantially Equivalent on 1990-04-25. Applicant: Healthcare Suppliers, Inc..

Clearance details

Applicant: Healthcare Suppliers, Inc.
Product code: Code FJK
Advisory panel: Gastroenterology, Urology
Date received: 1989-11-07
Decision date: 1990-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jackson, MS, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FJK

product code FJK

Death: 52
Malfunction: 3,430
Total: 3,482

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.